CeloNova Biosciences Inc.
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Latest From CeloNova Biosciences Inc.
Medical device companies – including Sientra, Endologix and Invacare – won loans from the US government’s Paycheck Protection Program, intended to protect jobs during the coronavirus pandemic. In total, nearly 1,400 device makers collected as much as $1.6bn, according to a Medtech Insight analysis of PPP data.
The German-headquartered firm is making a play to enter the US vascular intervention market, with two stents approved by FDA under original PMAs in the first quarter of 2017. Cardiovascular devices, in general, have gained the most novel-device approvals so far this year, followed by IVDs. Check out more from a Q1 look at US FDA approvals and clearances monitored by Medtech Insight's Approvals Tracker.
FDA's increasingly popular de novo classification pathway for moderate-risk devices that have no predicate accounted for five marketing go-aheads last month, four of which were for in vitro diagnostics.
Sanofi pushed ahead to advance its leadership in diabetes in a partnership with Hanmi; Pfizer bought Allergan in biopharma's biggest M&A to date, at $160bn. Boston Pharma's $600m financing contributed greatly to the early-stage venture category's 50% share of total financing.
- Implantable Devices