Channel Medsystems sued Boston Scientific (NYSE:BSX) this week over a $275 million buyout that Boston allegedly spiked over a former Channel employee’s alleged scheme to embezzle nearly $3 million from the women’s health company. Emeryville, Calif.-based Channel Medsystems developed Cerene, a cryogen-based endometrial ablation system designed to treat heavy menstrual bleeding that won CE Mark approval in the […]
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The 20 largest medical device companies in the world
The medical device industry saw even more consolidation over the past year, as evidenced by Medical Design & Outsourcing‘s newest Big 100 list. It used to be that a company had to have at least $100 million in annual revenue to make it on the list. This time around, No. 100 on the list is […]
LivaNova launches pivotal study for Vitaria heart failure device
LivaNova (NSDQ:LIVN) said today that it launched a pivotal study of its Vitaria neuromodulation implant for treating heart failure. The 800-patient Anthem-HFrEF study’s first subject was implanted with the Vitaria vagus nerve stimulation device at St. Luke’s Hospital in Cedar Rapids, Iowa, the London-based company said. Patients enrolled in the trial are slated to be randomized on […]
Medtronic launches study for bicuspid TAVR in low-risk patients
Medtronic (NYSE:MDT) said today that it’s launching a study of its CoreValve Evolut replacement heart valve in a low-risk patient population with a genetic form of heart disease, following a pair of FDA decisions about the treatment. The Fridley, Minn.-based medtech titan said the FDA granted an investigational device exemption for a single-arm trial of […]
FDA clears Contego Medical’s Paladin carotid balloon
Contego Medical said today that it won 510(k) clearance from the FDA for its Paladin carotid balloon with embolic protection. Raleigh, N.C.-based Contego said the Paladin device consists of an angioplasty balloon and a 40-micron filter for carotid stenting procedures. It won CE Mark approval in 2015 in the European Union, where it launched the following […]
AtaCor Medical raises $9m for sub-sternal pacer
AtaCor Medical said today that it raised nearly $9 million in a Series A round for the sub-sternal pacemaker it’s developing. San Clemente, Calif.-based AtaCor said Broadview Ventures and aMoon Ventures co-led the $8.8 million round, joined by an unnamed “corporate partner.” The proceeds are earmarked for further development of the pacer system. The device is designed to […]
Sensus Healthcare closes $15m offering
Sensus Healthcare (NSDQ:SRTS) today closed an offering that raised approximately $15 million for the development of its superficial radiation therapy devices. In the offering, the Boca Raton, Fla.-based floated 2.2 million shares at $6.80 apiece, for gross proceeds just shy of $15.0 million. The offering also includes a 30-day underwriter’s option to purchase an additional 330,882 shares […]
Reno hosts first complete AED deliveries via drone
The Biggest Little City in the World last week claimed another title when a single operator flew multiple drones delivering automated external defibrillators as part of a Federal Aviation Administration pilot program. The first flights were successfully completed using drones made by Flirtey that are designed to move heavier payloads over longer distances and for more […]
FDA pushes back on silicone breast implant study
The FDA last week pushed back at a large study showing an association between silicone breast implants and some rare diseases, standing by its record of warning the public about their risks – despite granting approvals to a slew of the implants in recent years. The study, published Sept. 14 in the Annals of Surgery, […]
France suspends blood collection using Haemonetics devices
UPDATED Sept. 17, 2018, with comment from Haemonetics. The French government reportedly decided on a precautionary suspension of the use of a blood collection device made by Haemonetics (NYSE:HAE) – used in half of all donations there – after receiving numerous reports of problems with the devices. Apheresis devices are used to separate plasma from blood […]
NFL players get in on $23m Series A for Miach Orthopaedics
The National Football League Players Assn. got in on a nearly $23 million Series A round for Miach Orthopaedics and its knee repair technology, the Boston-based company said today. Miach is developing bio-engineered implants for surgical connective tissue repair, aiming first at anterior cruciate ligament repair with its Bridge-Enhanced ACL Repair product, a sponge that’s designed to […]