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Digirad board approves deal to acquire ATRM Holdings
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...
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Senators question proposed device approval changes
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...
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Activ Surgical raises $13m
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...
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Advent Access wins CE Mark for dialysis device
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...
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Sonendo raises another $17m for acoustic-based root canal treatment tech
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...
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Fresenius to expand kidney research
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,...
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How one medtech company is working on solving the data dilemma
(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...
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Medtronic touts stroke data from HeartWare HVAD thoracotomy study
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...
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Valeritas touts study results
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...
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Intuitive Surgical recalls staple lots on manufacturing variation
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...
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FDA clears Biotronik’s third-gen injectable cardiac monitor
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...
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Medeon invests in ortho, urologic companies
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)....
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Agiliti snags Zetta Medical
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...
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Strata Skin Sciences inks Korea distribution deal
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...
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Inspire Medical scores reimbursement win from UnitedHealth
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...
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Japan approves iSchemaView’s Rapid stroke imaging device
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...
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Australia regulators publish guidance on recognized QMS standards
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...
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Clearside Biomedical licenses microinjector to Aura Biosciences
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...
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AxoSim touts results of nerve-on-a-chip study
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....
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Fresenius invests in BioIntelliSense
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...
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FDA approves ConTIPI Medical’s ProVate pelvic organ prolapse treatment
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...
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Cutera snags Vyaire Medical’s Mowry for CEO | Personnel Moves, July 9, 2019
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...
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DaVita, Fresenius slide on Trump threat to overhaul dialysis market
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...
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UL to close up notified body shop ahead of Brexit
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...
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5 Wearable Technologies Conference exhibitors you should know
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...
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