Outset Medical Inc. dropped 38% during intraday trading to reach its lowest point since going public in mid-2020 following its announcement that it began holding shipments of its Tablo hemodialysis system for home use in late May pending U.S. FDA clearance of a 510(k) submission for changes made to the device since its original clearance in March 2020. The stock which closed June 13 at $20.43, recovered some ground to close June 15 at $14.58, which is still 78% off the stock’s high in November 2020. Read More
Pediatric orthopedics company Orthopediatrics Corp. has signed a $33 million deal to buy competitor Pega Medical Inc. As part of the deal, Orthopediatrics will acquire Pega’s Fassier-Duval telescopic intramedullary system. The implant is designed to treat bone deformities in children with osteogenesis imperfecta. Orthopediatrics will pay a $31 million upfront cash payment plus $2 million in stock – which includes certain restrictions for three years. Read More
Diabeloop SA has just closed a series C funding round, securing $73 million to ramp global expansion for its DBL1 integrated smart system for patients with type 1 diabetes. “This will allow us to boost commercial roll-out and continue pursuing our growth strategy into Europe, the U.S. and Asia,” Erik Huneker, CEO of Diabeloop, told BioWorld. Read More
Regulatory harmonization for medical technology often seems more the stuff of gauzy dreams than bare-knuckle reality, but the Medical Device Single Review Program (MDSRP) is at the top of the list for a lot of device makers. Jeff Shuren, director of the U.S. FDA’s Center for Devices and Radiological Health (CDRH) device center, told an audience at this year’s annual meeting of the Food and Drug Law Institute (FDLI) that while the agency is very keen on the MDSRP concept, the agency would need help from Congress with the statute in order to take part, and thus the FDA will not be taking part in the MDSRP effort for now. Read More
Quoted European tech investor Gimv is setting up an independent life sciences arm and said it will increase both the size of its investments and the number of companies it backs. Read More
Quantitative imaging (QI) is making an increasingly larger footprint in clinical practice, and the U.S. FDA has rounded out a 2019 draft guidance spelling out the agency’s expectations regarding technical performance assessment of this class of products. Developers of software that provide quantitative data from imaging studies should expect to conduct studies that ensure the software controls for a wide range of sources of error, suggesting that studies of these algorithms could prove expensive. Read More
Med-tech firms raising money in public or private financings, including: Adient Medical, Brain Scientific, Forza, , Pulse Biosciences, Third Rock Ventures. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Boston Scientific, Global Access Diagnostics, Griintech, Inscopix, M.I. Tech, Mologic, Neurosigma, Synergy Innovation. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anchordx, Ibex, Ricoh. Read More
