Joint replacement implant maker Conformis (NSDQ:CFMS) is improperly using a Colorado man’s denial of benefits lawsuit to force Aetna to cover its customized knee implants, the health insurer recently argued in a federal court filing. Billerica, Mass.-based Conformis joined John Michael Schaub of Golden, Colo., in his lawsuit against Aetna, filed in May in U.S. District Court […]
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FDA clears Ambu single-use duodenoscope
Ambu announced today that FDA has cleared its aScope Duodeno — a sterile, single-use duodenoscope meant to avoid the deadly superbug outbreaks that cropped up around reusable versions of the scopes. Other companies — including Boston Scientific (NYSE:BSX), Hoya’s (TYO:7741) Pentax subsidiary, and Olympus (TYO:7733) — have been releasing either fully disposable duodenoscopes or duodenoscopes with disporable endcaps […]
Sirius Medical raises nearly $5m to commercialize non-radioactive tumor localization system
Sirius Medical has raised €4.4 million ($4.9 million) as it seeks to commercialize its Sirius Pintuition non-radioactive tumor localization system. News of the money raise comes about a month after the Eindhoven, the Netherlands-based Sirius announced that it had won a CE Mark for the system. FDA clearance is pending. The Series A round was […]
Smith+Nephew launches next-gen surgical robotics system
Competition continues to heat up in the robotic orthopedic surgery space, with Smith+Nephew (LON:SN) today announcing the launch of its next-gen Cori surgical system. Cleared by FDA and available for both total and unicompartmental knee arthroplasty, the handheld Cori robotics platform is meant to be faster than S+N’s previous Navio system. On top of Cori, […]
NovaSight raises $8m for lazy eye treatment device
Israeli startup NovaSight announced today that it has raised $8 million in a Series A round meant to support a large multi-center randomized pivotal study of its lazy eye treatment device. Study results will support potential FDA 510(k) clearance for the device. The money will also support development of future eye care products such as […]
FDA plans to resume onsite inspections later this month
FDA has a goal of restarting on-site inspections during the week of July 20 — four months after it temporarily halted them — though there will be changes due to the COVID-19 pandemic. The agency today said that it will pre-announce inspections to FDA-regulated businesses. Said FDA: “This will help assure the safety of the […]
U.S. investing $42m to boost BD syringe and needle production
HHS’s Biomedical Advanced Research and Development Authority is helping BD expand operations and manufacturing capacity in Nebraska to boost syringe and needle supplies for an eventual COVID-19 vaccine. Becton Dickinson (NYSE:BDX) said today that the total project will cost $70 million, with BARDA providing $42 million. The company expects the new capacity to be online within […]
CVRx raises $50m to support Barostim Neo commercialization
CVRx has raised $50 million in its latest round of equity financing — money the company will use to support the U.S. commercialization of its Barostim Neo heart failure treatment device. New investors Strategic Healthcare Investment Partners and Vensana Capital led the new funding round — with participation from other new investors, Hatteras Venture Partners […]
COVID-19 vaccines need to work at least half of the time, FDA says
FDA expects that any COVID-19 vaccine it licenses should prevent the disease or decrease its severity in at least 50% of people vaccinated, according to guidance that the agency released today. The recommendation, which FDA said reflects the advice the agency has provided vaccine developers in recent months, was part of an overall document called […]
Perimeter Medical Imaging to go public in Toronto
Perimeter Medical Imaging — creator of AI-based medical imaging tools for cancer surgery — plans to go public on the TSX Venture Exchange in Toronto on the week of June 29. The Toronto- and Dallas-based company is going public at the same time that it enters the commercial stage for its proprietary, FDA-cleared OCT imaging […]
Medtronic recall of DBS placement software is Class I
FDA said today that a Medtronic (NYSE:MDT) recall of software used to help place deep brain stimulation systems is Class I, the agency’s most serious level. The company in August 2019 recalled the auto-registration feature of its StealthStation DBS software due to inaccuracies caused by minor patient movements during the auto-registration process when used with NexFrame […]
