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FDA approves 1st-in-human trial for neural-enabled prosthetic hand
The FDA granted an investigational device exemption for the 1st-in-human trial of a neural-enabled prosthetic hand developed at Florida International University, backed by more than $2 million from the...
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Organogenesis acquires NuTech Medical
Organogenesis said today that it acquired NuTech Medical for an undisclosed price. The combined company plans to feature a portfolio of wound care products and surgical biologics. Birmingham,...
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MassDevice.com +5 | The top 5 medtech stories for March 28, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s...
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Elon Musk launches Neuralink AI venture for connected brain implants
Photo courtesy of Dan Taylor, Heisenberg Media. When he isn’t busy running Tesla or SpaceX, billionaire entrepreneur Elon Musk is reportedly setting up a new company called Neuralink. The artificial...
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New clinical guidelines for medical devices from Australian TGA
By Stewart Eisenhart, Emergo Group Medical device regulators at the Australian Therapeutic Goods Administration (TGA) have published new guidelines explaining what constitutes acceptable clinical...
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Trump FDA pick to recuse himself from agency decisions involving 20 companies
Donald Trump’s nominee to head the FDA, Dr. Scott Gottlieb, reportedly told ethics officials at the Office of Government Ethics he plans to recuse himself for 1 year from agency decisions on more than...
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ConvaTec investors deal 19% stake for more than $1B
The private equity owners of ConvaTec (LON:CTEC) drummed up about $1.21 billion (£975 million) by selling off a 19% stake in the British medical device maker. PE shops Nordic Capital and Avista sold...
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NuVasive wins 1st FDA nod for CoRoent multi-level cervical implant
NuVasive Inc. (NSDQ:NUVA) said today that the FDA granted 510(k) clearance for its CoRoent small interbody implant for fusion procedures in the cervical spine, claiming it as the 1st U.S. nod for a...
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FDA readies overhaul of inspection program
The FDA is reportedly set to revamp its inspection program in a few months, according to Dr. Jeffrey Shuren, the director of the safety watchdog’s Center for Devices & Radiological Health....
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ViaCyte, Gore ink co-development deal for synthetic pancreas
ViaCyte and W.L. Gore & Assoc. said today that they inked a co-development deal for the synthetic pancreas ViaCyte is developing to treat diabetes. The San Diego-based company’s Encaptra device is...
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Pulmatrix jumps 8% on rumors of potential Mylan takeover bid
Shares in Pulmatrix (NSDQ:PULM) jumped more than 8% today on rumors that the company’s collaboration partner Mylan (NSDQ:MYL) may be interested in a takeover bid. In 2015, the 2 companies inked an...
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Siemens CEO Kaeser: We’ll keep a majority stake in Healthineers after split
Siemens (NYSE:SI) will retain a majority stake in its Healthineers business after its planned initial public offering or spinout, CEO Joe Kaeser told a Swiss newspaper this week. The healthcare...
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Study: Knee replacement surgeries for OA patients less effective, more costly...
Knee replacement surgeries for patients with osteoarthritis provide minimal improvements in quality of life and are economically unattractive, according to a study released this week. Results from the...
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RepliCel touts tendon regeneration data for its fibroblast therapy
RepliCel Life Sciences (OTC:REPCF) touted data this week from its Phase 1/2 tendon repair study evaluating its type I collagen-expressing, hair follicle-derived fibroblasts as a treatment for Achilles...
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Merit Medical prices $136.5m offering
Merit Medical (NSDQ:MMSI) early this week announced an upcoming offering, looking to raise $136.5 million with funds slated to repay outstanding debt. The South Jordan, Utah-based company will look to...
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This LED-based device predicts radiation skin damage
[Image courtesy of Anaïs Leproux, Beckman Laser Institute]Researchers at UC Irvine’s Beckman Laser Institute are developing imaging to predict the skin damage that breast cancer patients will...
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Mylan shares down -3% after FDA rejects Advair generic
Shares in Mylan (NSDQ:MYL) dropped -3% to $40.46 apiece today after the FDA rejected its Abbreviated New Drug Application for the generic version of GlaxoSmithKline‘s (NYSE:GSK) Advair Diskus. The...
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MassDevice.com +5 | The top 5 medtech stories for March 29, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s...
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Researchers develop ‘nano cage’ to study cancer cell growth
Researchers at Kent State University and Kyoto University published work this week describing the genetic factors that help turn healthy cells into cancerous cells. The team’s work was published in...
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Study: Neuro-implants restore motion to quadriplegic patient’s arm
A quadriplegic man has had limited motion restored to his arm and hand as a result of a novel neuro-prosthesis connected to electrical stimulators in his arm, according to a new study. The 53-year old...
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