Intersect ENT (NSDQ:XENT) shares soared today on news that Medtronic (NYSE:MDT) has made a bid for the Menlo Park, Calif.-based ear, nose and throat condition treatment developer. Bloomberg reported the transaction late Tuesday, attributing the news to “people with knowledge of the matter.” Traders sent Intersect ENT shares up 38% in premarket trading. Medtronic declined to comment. […]
Conformis expects 50% drop in Q2 product revenue
Joint replacement implant maker Conformis (NSDQ:CFMS) said today that it anticipates a COVID-19-influenced 50% year-over-year drop in second-quarter product revenue. Releasing its preliminary results for the quarter ended June 30, the Billerica, Mass.-based company projected total revenue of $19.5 million for the quarter, which is down -1% year-over-year on a reported and constant currency basis. About […]
FDA approves Cochlear sound processor
Cochlear Ltd. (ASX:COH) announced today that it received FDA approval for three new products in its suite of implantable hearing technology. Lone Tree, Colo.-based Cochlear won approval for its Nucleus Kanso 2 sound processor, Nucleus 7 sound processor for Nucleus 22 implant recipients and Custom Sound Pro fitting software, according to a news release. Cochlear touts […]
Axonics’ SNM system wins FDA nod for 3T-MRI scans
Axonics Modulation Technologies (NSDQ:AXNX) announced today that it has won FDA approval for full-body 3 Tesla (T) MRI scanning for patients implanted with its r-SNM sacral neuromodulation system. The premarket approval supplement represents an upgrade from a previous PMA conditional labeling for r-SNM, which allowed for for full-body scans using 1.5T MRI scanners. With this incremental […]
Ancora Heart wins IDE for ventricular restoration system
Ancora Heart announced today that it received FDA investigational device exemption (IDE) for its AccuCinch ventricular restoration system. AccuCinch is designed to treat patients with heart failure and reduced ejection fraction (HFrEF) by directly reshaping the left ventricle of the heart to address the fundamental issue in the progression of systolic heart failure, according to […]
CoreLink wins FDA clearance for standalone cervical spine system
CoreLink announced today that it received FDA 510(k) clearance for its F3D-C2 standalone cervical system for ACDF procedures. The F3D-C2 standalone cervical device eliminates the need for a supplemental fixation plate to make ACDF (anterior cervical discectomy and fusion) procedures easier to complete and a faster process overall. St. Louis-based CoreLink’s system includes its 3D-printed […]
FDA approves Mainstay Medical neurostim device
Mainstay Medical announced that it received FDA premarket approval for its ReActiv8 implantable neurostimulation system for chronic low back pain. ReActiv8 treats intractable chronic low back pain associated with multifidus muscle dysfunction, as evidenced by imaging or physiological testing in adults who have failed therapy and are not candidates for spine surgery, according to a […]
CEO Kevin Lobo says Stryker ready to regain lost momentum
Stryker (NYSE:SYK) CEO Kevin Lobo said today that the company is preparing to restart “a number” of idled production lines next month as it climbs out the crater created by COVID-19. In an interview on the DeviceTalks Weekly Podcast, Lobo said the company is rebounding from its low point in April, when its sales fell almost […]
Smith & Nephew Regeneten bioinductive implant wins CE mark
Smith & Nephew (NYSE:SNN) announced today that its Regeneten bioinductive implant for rotator cuff procedures received CE Mark approval in Europe. Regeneten, a collagen-based implant, supports the body’s natural healing process by inducing the growth of new tendon-like tissue to biologically augment the existing tendon and disrupt disease progression. The implant, which is the size of […]
15 heart devices that could boost their manufacturers’ sales
Before the coronavirus pandemic hit, medtech companies large and small were making notable news with a number of innovative heart devices. Some of these same companies took a big hit to their bottom lines when the danger of spreading COVID-19 and using up precious personal protective equipment convinced hospitals to limit non-urgent procedures. Now hospitals […]
Aesculap launches hydrocephalus valve
Aesculap recently launched its M.blue hydrocephalus valve. The valve is adjustable gravitational valve that features an integrated fixed pressure differential valve during the most active time of the day, according to the company. The fixed pressure differential valve addresses posture changes. “We are very pleased to be able to continue to provide healthcare teams with […]
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