Digirad Corp. (NSDQ:DRAD) said this week that its board of directors approved a deal to buy ATRM Holdings as a “kick-off” transaction to convert Digirad to a diversified holding company.

As part of the acquisition, Digirad plans to create Series A non-convertible, cumulative, perpetual preferred stock with a stated value of $10 apiece. ATRM shareholders are slated to receive consideration consisting of 0.03 shares of Digirad Series A preferred stock for every ATRM common share.

Also, each Series B preferred stock of ATRM will be exchanged for 2.5 shares of Digirad’s Series A preferred stock, according to Digirad.

The transaction is slated to close in the third quarter of 2019, pending approval by ATRM shareholders.

Following the acquisition of ATRM, the new team will include Jeffrey Eberwein (chairman of Digirad), Matthew Molchan (Digirad Health’s CEO), Daniel Koch (ATRM’s CEO), David Noble (COO and CFO of Digirad) and Hannah Bible (VP of Digirad’s legal division).

“Digirad believes that converting into a diversified holding company with a shared services center will create significant value for Digirad stockholders over time because the conversion is expected to improve future revenue, cash flow, and earnings growth, and create a platform for future bolt-on acquisitions and other growth opportunities,” the company said in a press release.

U.S. Senators Patti Murray (left) and Elizabeth Warren

U.S. Senators Patti Murray (D-Wash.) and Elizabeth Warren (D-Mass.) are challenging an FDA budget proposal that would ease the approval process for certain medical devices.

In a June 24 letter to Acting Commissioner Dr. Ned Sharpless and Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health, Murray and Warren target the “progressive approval for devices” program included in the agency’s fiscal year 2020 budget that would expand the conditional approval pathway for animal drugs to human medical products. Former FDA Commissioner Scott Gottlieb had “assured us” this expansion would not take place, the senators wrote.

“We strongly oppose the expansion of the conditional approval pathway to human drugs and devices, and we are seeking clarification on whether the FDA is pursuing this policy despite then-Commissioner Gottlieb’s commitments to the contrary,” the letter says.

The FDA established the conditional approval pathway for animal drug development in 2004, allowing drugs for “minor species” or for “minor uses in a major species” to bypass the traditional FDA approval process without fully demonstrating their effectiveness. They have five years to meet the “substantial evidence” of effectiveness standard.

In August 2018, the Animal Drug User Fee Act (ADUFA) further expanded the conditional approval pathway by creating a 10-year pilot program that allows other animal drugs to qualify, as long as the drug is “intended to treat a serious or life-threatening disease or addresses an unmet animal or human health need and for which the Secretary determines that a demonstration of effectiveness would require a complex or particularly difficult study or studies.”

“We strongly objected to any expansion of the conditional approval pathways in ADUFA that would have applied to human medical products, and we remain committed to ensuring that the FDA does not extend this approval pathway to human drugs or medical devices,” the senators wrote.

The FDA’s FY 2020 budget proposal includes references a proposed “progressive approval for devices” that would allow certain devices to ”be eligible for provisional approval based on a demonstration of safety and performance plus additional risk mitigations.” Devices approved this way could remain on the market “after an established tin1e period only after a demonstration of reasonable assurance of safety and effectiveness.”

The provisional approval process seems “hardly distinguishable” from the conditional approval that Gottlieb said the agency would not pursue, the senators wrote. “Whether ‘progressive,’ ‘provisional’ or ‘conditional,’ the proposal is particularly alarming, given the FDA’s already-lenient regulatory framework guiding medical device approval standards. While new drug sponsors must show “substantial evidence” of effectiveness, new device sponsors must only show a “reasonable assurance of … safety and effectiveness.”

Shuren has long advocated for the expansion of approval pathways and has indicated that provisional and conditional approval are the same, the senators added. Warren and Murray, a ranking member of the Senate Committee on Health, Education, Labor, and Pensions, asked Sharpless and Shuren to respond to their general concerns and to specific questions by July 8.

Activ Surgical has raised nearly $13 million as the company continues development of its Smart Tissue Autonomous Robot (STAR).

The Boston-based company has been seeking nearly $19 million in the money-raise, according to a Form D filed with the U.S. Securities and Exchange Commission on July 1.

Founded in 2017, Activ’s initial technology is STAR. Developed out of Children’s National Medical Center in Washington, D.C., the robot uses near-infrared fluorescent (NIRF) markers to provide a biocompatible, near-infrared 3D tracking system. The result, according to the robot’s developers, is accurate 3D tracking of tissue and surgical tools — an improvement over standard optical tracking technology.

Activ Surgical describes its overall goal as the “integration of advanced computer vision, artificial intelligence and robotics designed to seamlessly fit within operating room workflow while providing advanced imaging and diagnostic accuracy during surgery.” Robots could autonomously engage in soft tissue surgery under the supervision of a surgeon.

Activ Surgical announced in March that it had tapped Todd Usen, the former president of Olympus Medical Systems, as its first CEO.

The av-Guardian vascular access system designed for hemodialysis patients. (Image from Advent Access)

Singapore-based vascular access device company Advent Access said it has received the CE Mark for its av-Guardian technology designed to create vascular access for dialysis patients.

The device-guided needling platform features the company’s “guardian guide-door” technology for accessing arteriovenous fistulas, which it claims can reduce wear and tear on the dialysis patient’s veins. The technology may be used in a dialysis center or at home, regardless of the types of dialysis machine being used, according to the company

“Receiving CE Mark approval for av-Guardian is an important milestone in our mission to provide a more comfortable treatment for patients suffering long term end-stage kidney disease and to reduce the cost burden of maintenance dialysis,” Advent Access CEO Peh Ruey Feng said in a news release. “Our focus now is to work with high-quality manufacturing and distribution partners to realize the impact we can make in potentially changing the way hemodialysis patients receive treatment either in the center or at home.”

The av-Guardian technology was recently evaluated in a first-in-human study conducted at Singapore General Hospital and National University Hospital of Singapore, with support from the National Kidney Foundation. The study was a non-randomized, prospective clinical investigation to assess the safety and clinical performance of the av-Guardian across 216 hemodialysis sessions in patients with native AV fistulas. The study showed that av-Guardian met all safety and performance endpoints, achieving 94% to 98% successful access to the AV fistula, with 86% to 90% success at the first needle attempt, according to the company.

Sonendo has brought in $17 million — its latest multimillion-dollar money raise as it expands marketing of its GentleWave system that uses acoustic energies to better clear out a tooth’s root canal system.

The roughly $17 million matches the full amount that Laguna Hills, Calif.–based Sonendo was seeking to raise, according to a Form D the company filed with the U.S. Securities and Exchange Commission on July 1.

The news comes about three months after Sonendo announced the Canada launch of GentleWave, with CEO Bjarne Bergheim touting increased demand for the procedure.

GentleWave uses a combination of procedure fluids, vortical flow and broad-spectrum acoustic energies to debride and disinfect the root canal system. The system is able to reach event undetected spaces, enabling a minimally invasive procedure that leaves more of the tooth structure intact, according to Sonendo.

The 13-year-old company has announced other multimillion-dollar raises in the past, including $35 million in 2016.

Fresenius Medical Care (NYSE:FMS; ETR:FRE) said this week that it is expanding its clinical research activities. Frenova Renal Research, previously a Fresenius Medical Care North America subsidiary, will now offer its services worldwide and will be integrated into a new global medical office headed by chief medical officer Dr. Frank Maddux.

Frenova offers services for the clinical development of medicines and medical products in the field of kidney research. This offering, previously limited to North America, will now be linked with the corresponding services of Fresenius Medical Care’s Europe, Middle East and Africa (EMEA) and Latin America regions and bundled under Frenova. This will enable the company to draw on a network of more than 550 researchers at over 350 locations.

“Frenova is active at the intersection of clinical research and patient care,” Maddux said in a news release. “No other provider of clinical development services understands the medical needs of people living with kidney disease as well as we do. By making this expertise available worldwide, we will enable a faster, more efficient development of medications and other products. This is an additional, important building block for improving their quality of life.”

(Image by Rishi Deep on Unsplash)

The electronic medical record was designed to better track patient care, but it has had unintended consequences. Physicians are bombarded with digital patient information all day long, reducing their patient eye-to-eye interactions and adding hours to their workday.

A 2016 American Medical Association study found that physicians spent about two hours on electronic health record and other desk work per day for every hour that they provide direct clinical face-time to patients. Outside office hours, physicians spend another one to two hours of personal time each night doing additional computer and other clerical work, the study found.

Get the full story on our sister site, Medical Design & Outsourcing.

Medtronic (NYSE:MDT) today touted stroke data from the Lateral trial of its HeartWare HVAD left ventricular assist device involving implantation via thoracotomy instead of open surgery.

With a thoracotomy implantation, surgeons insert the pump via a small, lateral incision between the left ribs and make a second small incision to accommodate the pump’s outflow graft. Fridley, Minn.-based Medtronic said Lateral results presented at the annual meeting of the American Society for Artificial Internal Organs showed that 95% of thoractomy patients were free from disabling stroke at two years.

Adverse events were more likely in the first 30 days after implantation and declined significantly after that, as measured by events per patient year. Bleeding events moved from 1.53 to 0.51 per patient year; arrhythmia events slid from 3.22 to 0.26; and from 0.51 to 0.12 for stroke between the 30- and 180-day marks, the company said.

The risk of late stroke was 0.05 EPPY in years one to two post-implant and the survival rate was 87% at two years, according to Medtronic.

“These data give us more comprehensive information showing low adverse event and stroke rates for end-stage heart failure patients who receive the HVAD system,” cardiac rhythm & heart failure CMO Dr. Rob Kowal said in prepared remarks.

“Remembering my earliest experiences with the very first HVAD system implant in patient more than 15 years ago, I’ve seen both the significant benefits and also the risks for patients who receive a ventricular assist device. These new data are impressive,” added study investigator Dr. Georg Wieselthaler of UC San Francisco. “Many of us have dedicated our lives’ work to improving this therapy, including minimizing adverse events. The HVAD pump’s small size lends itself to the less-invasive surgical approach, and to see 95% freedom from disabling stroke at two years with the HVAD system implanted via thoracotomy reinforces that we are making dramatic strides in this therapy.”

Medtronic also said it plans to launch a global registry study of thoracotomy implantations in bridge-to-transplant and destination therapy patients.

Valeritas (NSDQ:VLRX) today announced the results of a study that showed patients using its V-Go wearable insulin delivery device needed less insulin, had lower A1c levels and reduced diabetes-related medication cost compared with patients using multiple daily injection (MDI) therapy.

The retrospective study by the Bridgewater, N.J.-based company used information from the HealthCore Integrated Research Database (HIRD).

Get the full story on our sister site, Drug Delivery Business.

Intuitive Surgical (NSDQ:ISRG) is recalling 23 lots of staples used with its da Vinci Xi robot-assisted surgery device after internal testing turned up a manufacturing “variation” that could cause an incomplete staple line.

The Sunnyvale, Calif.-based company said the problem with some of its da Vinci Xi SureForm 60 Black and Green Reloads has a low likelihood of occurring. The variation could result in the reloads failing to deploy three adjacent staples, causing a “minor delay” to reinforce the staple line, the company said.

The risk depends on the type of procedure involved, Intuitive said.

“In rare situations there is a theoretical possibility that this could potentially lead to an air leak or an anastomotic leak which may require an additional procedural intervention,” according to Intuitive’s field safety notice.

Biotronik said today that it won 510(k) clearance from the FDA for its Biomonitor III injectable cardiac monitor.

Oswego Lake, Ore.-based Biotronik said the Biomonitor III is 60% smaller than its predecessor and offers increased signal quality and a patient app that reports system diagnostics. The device is approved as MR-conditional for both 1.5T and 3.0T scans.

“Receiving FDA clearance on Biomonitor III further demonstrates Biotronik’s continued dedication to designing innovative technology solutions that improve patient lives,” president Ryan Walters said in prepared remarks. “This device maintains exceptional functionality in detecting arrhythmia and its reduced size and novel delivery tool simplifies the injection procedure. Physicians and patients can count on Biomonitor III to deliver timely and accurate data to identify potentially life-threatening cardiac arrhythmias faster and more confidently than ever before.”

“Biomonitor ICMs have a proven track record for exceptional signal quality,” added Dr. Raul Weiss of Columbus, Ohio. “Biomonitor III expands the existing diagnostic utility of these devices while simplifying the procedure. Biomonitor III is an exceedingly small device with market-leading four year longevity. When physicians are not burdened by poor signal quality, clinically irrelevant data, inaccurate, or worse, missed detections – more time can be devoted to ensuring a timely and accurate diagnosis.”

Medeon Biodesign (TPEx:6499)  said today that it recently led and closed investments in an orthopedics startup and a company whose device was designed to treat benign prostatic hyperplasia (BPH).

Panther Orthopedics is a Silicon Valley startup working on fixation solutions for orthopedic extremity applications. Prodeon is a Taiwan-based company offering a simple, office-based treatment option for BPH patients who are seeking immediate relief from lower urinary tract symptoms (LUTS).

Panther Orthopedics’ FDA- 510(k) cleared Puma System is designed to treat orthopedic injuries with the benefits of screws and flexible fixation devices but without their shortcomings. The Puma body’s spring-like design provides initial and continuous compression without the need to overtighten, according to Taiwan-based Medeon Biodesign. The Puma system has been commercially available since November 2018.

Taiwan-based Prodeon’s investigational device, the Xflo expander system, is a novel, minimally invasive, office-based treatment that offers a simple option to conventional surgery or drugs for resolving BPH symptoms. The system successfully completed its first clinical use in Australia and the Republic of Georgia, according to Medeon Biodesign.

“Medeon has built an innovation platform that partners with physicians and entrepreneurs to solve unmet medical needs, by bringing innovative ideas from concept to commercialization,” said Medeon chairman & CEO Yue-Teh Jang in a news release. “With both the resources to fund projects and the capabilities to execute them, this platform combines the strengths of a traditional medtech venture capital firm and those of a medtech development firm. The two recent investments, in Panther Orthopedics and Prodeon, are perfect examples of executing this unique business model with a combination of funding, development expertise, manufacturing capabilities, and industry relations to accelerate medtech development.”

Healthcare technology management firm Agiliti said it acquired Zetta Medical Technologies for an undisclosed amount.

Lake Zurich, Ill.-based Zetta offers engineering services, parts and pre-owned medical imaging equipment via a network of OEM trained-engineers, according to Minneapolis-based Agiliti, formerly known as Universal Hospital Services.

“Zetta’s specialized capabilities and technical expertise are an ideal complement to our expanding platform of clinical engineering services,” CEO Tom Leonard said in prepared remarks. “This acquisition builds upon our outsourced and supplemental biomedical service models and enables us to further extend into full-service clinical engineering for high-end imaging devices. Our teams share a common approach based on the highest quality standards of medical device management, as evidenced by our mutual certifications to ISO 13485:2016. I look forward to delivering our combined capabilities to customers.”

“Over the past 12 years, we’ve built a strong reputation as a highly skilled and reliable partner,” added Zetta founder & president Mike Ghazal. “Agiliti shares our commitment to service, customer responsiveness and uncompromising quality, and provides a platform that will enable us to serve more customers as part of a broader, value-based solution portfolio.”

In July 2018 Zetta won 510(k) clearance from the FDA for its Zoom MRI software.

Strata Skin Sciences (NSDQ:SSKN) today announced a new Korean direct distribution deal with Kosmo Meditech for direct capital sales and direct recurring revenue sales in Korea.

Kosmo Meditech has worked with Strata Skin Sciences for more than 13 years. The deal with help strengthen Strata’s Xtrac excimer laser value proposition in Korea and expand its installed base of over 250 devices in the country, according to the company.

“We have been a proud partner in the Xtrac business in Korea for over 13 years and are very happy to be the first international launch partner of Strata’s recurring business model. The benefits of the model will allow Kosmo to further strengthen its leadership position in the dermatology device space in Korea,” chairman of Kosmo Michael Nam said in a press release. “We look forward to many more years of providing a full business solution, which includes the highest quality excimer lasers into the Korean clinical dermatology market, now with a unique strategy that leverages both companies’ strengths as a platform for growth.”

Through the deal, Horsham, Penn.-based Strata Skin Sciences plans to target over 1,800 dermatologists in Korea. Strata Skin Sciences expects to see the impact of the deal in late 2019 or early 2020.

“We are very pleased to expand globally and to bring our unique business model to Korea with our strategic partner Kosmo Meditech. This is a tremendous opportunity as we leverage our strong balance sheet and Kosmo’s in-country distribution network,” president and CEO of Strata Dolev Rafaeli said. “We look forward to driving market share gains as well as seeing our proven business growth engine validated in a new market.”

Inspire Medical Systems (NYSE:INSP) logged another reimbursement win, this time with the nation’s largest private insurer, UnitedHealth.

Minneapolis-based Inspire makes an eponymous device designed to treat obstructive sleep apnea using hypoglossal nerve stimulation. UnitedHealth has about 41 million lives under coverage, Inspire said.

“We are very pleased to receive this positive coverage decision from UnitedHealthcare. As health plans continue to update their coverage policies to include Inspire therapy, an increasing number of patients and physicians will have access to our innovative therapy,” president & CEO Tim Herbert said in prepared remarks. “With the addition of UnitedHealthcare, we now have 35 coverage policies, representing approximately 125 million members, that cover Inspire therapy compared to 3 million members one year ago.”

The UnitedHealth policy for Inspire covers patients whose previous continuous positive airway pressure therapy failed for their moderate to severe OSA.

Under its policy, UnitedHealthcare considers Inspire’s U.S. Food and Drug Administration (FDA) approved hypoglossal nerve neurostimulation device to be medically necessary for the treatment of moderate to severe OSA when specified criteria are met, including a previous attempt at  (CPAP) treatment as well as patient selection consistent with the FDA’s approval guidelines.

INSP shares got a bounce on the news, rising 5.9% to $67.65 apiece today in mid-day trading.

Early this year Inspire landed positive coverage decisions with a pair of Blue Cross Blue Shield affiliates.

iSchemaView today announced that it received registration approval in Japan for its Rapid imaging platform.

The company received registration approval through the Japanese Pharmaceutical Affairs Law and through a third party review by the Japanese Assn. for the Advancement of Medical Equipment for the Rapid imaging platform.

Rapid is designed to give physicians a fast, fully automated and easy-to-interpret imaging system that can help doctors make clinical decisions about stroke.

“Stroke remains the fourth most common cause of death in Japan, and as the population ages, stroke is likely to become an increasing health burden on the country,” National Cerebral & Cardiovascular Center chief of cerebrovascular medicine Dr. Manabu Inoue said in a press release. “With Rapid’s AI-powered imaging technology, we will be able to better address our patients to provide them with the best routes of care, improving their chances of recovery.”

The Rapid technology features artificial intelligence that combines deep learning, machine learning and expert feature extraction, according to iSchemaView. The imaging platform features several fully automated imaging techniques, including Rapid CTP for fully-automated perfusion maps, Rapid MRI for fully-automated diffusion and perfusion maps, Rapid CTA to automatically deliver CT angiography maps and Rapid Aspects to automatically identify early ischemic change on non-contrast CT scans.

Results from the imaging system are delivered through PACS, email, text, the Rapid app or corporate partner workflow systems.

“With approval for Rapid in Japan, we extend a global footprint that gives more hospitals the tools they need to help stroke patients achieve the best outcomes and quality of life,” SVP of worldwide operations Anil Singhal said. “Our goal is to help as many stroke patients as possible by delivering the only clinically validated, next-generation imaging technology available.”

By Kate Jablonski, Emergo Group

The Australia Therapeutic Goods Administration (TGA) published guidance on its recent update to Medical Device Standards Order (MDSO), Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019, on June 19.

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

Clearside Biomedical (NSDQ:CLSD) said today that it licensed its microinjector technology to Aura Biosciences for use with Aura drug candidates in treating ocular cancers.

Alpharetta, Ga.-based Clearside’s Suprachoroidal Space Microinjector is designed to deliver therapeutics into the suprachoroidal space between the sclera and choroid of the eye. Aura, based in Cambridge, Mass., is developing viral nanoparticle conjugates designed to seek out and eliminate cancer cells.

Get the full story at our sister site, Drug Delivery Business News

A new study of AxoSim’s Nerve-on-a-Chip technology shows that the platform accurately provides key physiological readouts that could help speed the development of drugs to treat neurological disorders.

The study also shows that Nerve-on-a-Chip technology is the first all-human in vitro model that can measure critical factors that were formerly only available using live animal models. These include robust axonal outgrowth, myelination of human stem cell-derived neurons by primary human Schwann cells, and evaluation of nerve conduction velocity, according to the New Orleans-based company.

Get the full story on our sister site, Drug Delivery Business.

Fresenius Medical Care (NYSE:FMS; ETR:FRE) today announced an investment in BioIntelliSense for an undisclosed amount.

Denver-based BioIntelliSense is developing a medical-grade data services platform for continuous remote health monitoring, predictive analytics and algorithmic clinical insights.

Through the agreement, Fresenius will use the advanced analytics and artificial intelligence to develop medical wearables for clinical pathways that allow clinicians to be alerted for early intervention of medical conditions. The company says the combination of the two technologies can help prevent complications and reduce unnecessary and costly hospitalizations.

Fresenius earlier this month expanded into clinical research activities into kidney research.

ConTIPI today announced FDA approval for its ProVate device.

ProVate is designed to treat pelvic organ prolapse in women. It’s a disposable, non-invasive treatment option that supports lateral vaginal walls and mechanically prevents cervical/vault descent, according to the company. It blocks further descent of the anterior/posterior walls within its central piece and is available in six different sizes.

“For many years we have been working to promote pelvic floor solutions and products that will help every woman conduct a normal life and fully control her medical condition,” founder and CEO Elan Ziv said in a press release. “This is an innovative, groundbreaking product enabling women to control their medical problem and we assume that the product will soon be available to millions of women worldwide who would be interested in treatment.”

The ProVate device won CE Mark approval in 2017 after being in development for more than four years.

Cutera (NSDQ:CUTR) said today that it snagged Vyaire Medical CEO David Mowry to be its new CEO, effective immediately.

The aesthetic device maker in January fired president & CEO James Reinstein after the company missed expectations for its 2018 top line, naming COO Jason Richey as interim chief executive.

Mowry led Tornier to a $3.3 billion merger with Wright Medical in October 2015. After leaving the COO role at Wright the next year, he was tapped to lead Vyaire Medical, a rollup of four respiratory businesses BD acquired in the March 2015 deal for CareFusion. Initially a joint venture partner in Vyaire with private equity shop Apax Partners, BD later dealt its 49.9% stake to Apax for $435 million.

Mowry’s resume also includes a stint as president of Covidien’s neurovascular business, Brisbane, California-based Cutera said.

“We are pleased to welcome David Mowry as Cutera’s CEO,” chairman Daniel Plants said in prepared remarks. “Dave is a highly regarded leader in the medical device industry, with a proven track record of building great businesses and creating shareholder value. We’re confident that Dave’s vision, operational discipline and commercial acumen make him the ideal leader for Cutera, and we’re excited to leverage his experience to help Cutera reach the next level.

Cutera also said that its preliminary second-quarter numbers “exceeded consensus growth estimates and its own revenue forecast.” Analysts on Wall Street will be looking for adjusted losses per share of -3¢ on sales of $41.6 million when Cutera releases its Q2 numbers August 8.

“On behalf of Cutera’s board of directors, I would like to thank Jason Richey for his outstanding efforts serving as our interim CEO. Under Jason’s direction, Cutera’s senior management has put in motion a number of important initiatives and stabilized the business, as evidenced by the preliminary financial results which we are also issuing today – exceeding revenue expectations in both quarters under his watch. Jason is a talented leader and, in recognition of his many contributions, we have promoted him to the role of president, the first executive to hold this title at Cutera. Finally, our search committee, comprised of directors Gregory Barrett and Timothy O’Shea, deserves commendation for its thorough process, which culminated in the identification and recruitment of Dave Mowry as our next CEO,” Plants said.

“I am delighted to have the opportunity to lead Cutera, a company with an exceptionally strong product portfolio and a reputation for delivering differentiated technology developed with the clinician customer in mind. The company’s unique, singular focus on the aesthetics market provides it with the ideal scale and scope to win,” Mowry added. “I am especially excited to work with the talented team at Cutera to deliver sustainable growth and improved profitability while, most importantly, continuing to deliver market-leading technology to our valued customers. I am confident in our ability to position Cutera for long-term success and look forward to working together to achieve our full potential.”

 Camstent puts ex-PneumaCare CEO Harwood in the corner office
Bacterio-phobic polymer coatings maker Camstent said it put former PneumaCare CEO Mark Harwood into the corner office.
Read More

 Pure Bioscience CEO Lambert steps down
Pure Bioscience (OTC:PURE), which is developing a non-toxic silver dihydrogen citrate antimicrobial, said CEO Hank Lambert is retiring effective August 7, replaced in an acting capacity by chairman and largest shareholder Tom Lee. Pure also said it’s moving its HQ from San Diego to Rancho Cucamonga, Calif., to co-locate with Lee-led Swabplus.
Read More

 Dentsply Sirona taps Cardinal Health vet Gomez for CFO
Dentsply Sirona (NSDQ:XRAY) yesterday said it tapped former Cardinal Health finance chief Jorge Gomez to be its CFO.
Read More

 Cerner lures Medtronic vet Pratt for chief HR role
Cerner (NSDQ:CERN) said yesterday that it lured former Medtronic (NYSE:MDT) executive Tracy Pratt to be its new chief human resources officer.
Read More

• Warren: Gottlieb should resign from Pfizer board
• Neuronetics swaps CFOs
• Tu is new CMO at Inari Medical
• Ocular Therapeutix names Kitchen as COO
• RIP Medline co-founder Jim Mills

Shares of dialysis providers DaVita Healthcare (NYSE:DVA) and Fresenius (NYSE:FMS) took a hit today after a report surfaced that the Trump administration is readying an overhaul of the kidney treatment market.

The president plans to issue an executive order tomorrow that would seek to incentivize kidney transplants and home hemodialysis in a bid to lower the federal government’s annual $100 billion kidney care tab, Politico reported, citing “two individuals with knowledge of the announcement.”

The strategy involves new payment models from the U.S. Health & Human Services Dept. designed to move patients out of brick-and-mortar dialysis clinics and into their own homes for treatment, according to “four individuals familiar with the plan” quoted by the website. HHS also plans to increase prevention and screening for kidney disease.

HHS said it couldn’t comment on potential rulemaking. The White House did not respond to requests for comment, Politico reported.

The news sent shares of DaVita and Fresenius, which dominate the hemodialysis clinic market, down significantly today. DVA shares were off -7.4% to $51.40; FMS shares slid -5.5% to $37.28, both in early afternoon trading.

“Two companies effectively control the market and neither currently are financially incentivized to change behavior,” Raymond James analyst and former HHS official Chris Meekins told Politico. “The administration needs to put forward enough carrots to encourage new market entrants and enough sticks to force the current players to alter behavior if real change is to occur.”

Meekins said the president could announce a goal of 80% of kidney patients either receiving a kidney transplant or using home dialysis by 2025, Bloomberg reported.

The U.K.’s pending secession from the European Union prompted UL International to start closing up shop as a notified body for medical device approvals.

British voters in June 2016 approved withdrawing from the E.U. on a 51.9% to 48.1% vote. An initial Brexit deadline of March 29 was broken after Parliament voted three times to reject deals brokered with the E.U., raising the specter of a unilateral “no-deal” Brexit before the newest deadline of Oct. 31.

Get the full story at our sister site, Medical Design & Outsourcing

The 34th edition of the Wearable Technologies Conferenceseries is taking place today and tomorrow in San Francisco.

Co-located with Semicon West, the Wearable Technologies Conference offers a number of panels to discuss wearables in healthcare and IoT, as well as conference exhibitors and networking opportunities.

Here are five companies touting their latest wearable technologies at this year’s conference.

Next >>