Edwards Lifesciences bumped up its transcatheter heart valve sales estimate for 2015 due to what it anticipates will be a strong U.S. launch for its third-generation TAVR device, Sapien 3. It was approved in June within a day of an FDA approval for a similar device from Medtronic, so the next quarter's earnings will start to tell the tale on how that U.S. next-gen TAVR competition will play out.
One of a handful of obesity devices aiming for the U.S. market has been sidelined. Australian company GI Dynamics has opted, after discussions with the FDA, to terminate its pivotal trial for its EndoBarrier due to safety concerns. The trial had already been placed on hold by the agency in March due to the incidence of hepatic abscess.
InSleep Health just received FDA clearance for its Cloud9 Anti-Snoring System, which deploys continuous low positive airway pressure to help snorers (and their annoyed partners). The prescription-only device consists of an air-flow unit and headgear worn around the head that delivers low-pressure air into the nose. The two components are connected via a hose.
Innovations in aesthetic medicine have proven lucrative in the medical device industry, given a growing and aging population with disposable income. Investors are betting that a dermal filler to treat acne scars--that's the first approved by the FDA--could be the next ticket to successful commercialization in aesthetics.
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Abbott will buy two mitral valve replacement startups, moving it even further into med tech after a series of high-profile deals last year. It obviously sees the sector as a way for it to plan for long-term growth--since its innovative biopharma candidates went with AbbVie when the companies split in early 2013.
ResMed increased its focus on sleep disorder devices by acquiring China's Curative Medical for an undisclosed sum, in an attempt to gain a foothold in a fast-growing market.
Rehabilitation specialist AlterG has wrapped up $15 million in debt to back its products that include a leg-worn motor assistance device AlterG Bionic Leg as well as a low-gravity treadmill. The financing comes during an ongoing renaissance for novel mobility assistance devices.
Monroeville, PA-based startup Rinovum Women's Health has gained $6 million to back its commercialization efforts for its home-use conception assistance device that was cleared by FDA last fall. That's according to a SEC filing; the financing is an expansion of an infusion of just $700,000 it reported earlier this year .
Spinal cord stimulation is the med tech trend du jour, and researchers are harnessing the technology to create a noninvasive method that helps restore movement in paralyzed individuals.
Healthcare was one of the strongest segments at German conglomerate Siemens last quarter, both in terms of sales growth and profitability. That could help insulate this business, comprised mostly of imaging and diagnostics, from an ongoing restructuring that aims to trim employees and costs from its worst performing businesses.
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Massachusetts' EyeGate Pharmaceuticals picked up $10 million in an IPO do-over, raising cash to support its sole clinical candidate.
Struggling Vivus is short on cash, and it's got a pricey cardiovascular outcomes trial looming in its future. Its fix? Pare down costs once again--or, in the words of RBC Capital Markets analyst Simos Simeonidis, "amputate a limb so that the patient may live."