The firm announced the first U.S. implant for its investigational Micra transcatheter, leadless pacing system, and the global launch of its miniature Reveal LINQ implantable cardiac monitor.
The race to develop a fully functional artificial pancreas for patients with diabetes is entering the later stages, and the first such device could be ready for regulatory submission in the next few years. Medtronic has achieved notable success in this area to date, but positive clinical studies have put J&J in a good position as well, and the medical community is watching closely as the major developments in this groundbreaking endeavor continue to move forward.
At the end of October, Apollo Endosurgery announced that it would acquire certain obesity assets from Allergan: Lap-Band, one of the most well-known brands in bariatric surgery, and Orbera, Allergan’s intra-gastric balloon system, the leading such product in Europe. It’s not unusual these days for large companies to unload under-performing businesses, but the Allergan deal is striking because of its choice of partner. Apollo Endosurgery is a small organization acquiring a much larger one.
Drug-coated balloons have emerged as one of the next major product segments within interventional cardiology, particularly for the treatment of peripheral arterial disease, but they appear to have hit their first major bump in the road. In November, Medtronic notified clinicians that it was recalling and discontinuing sales of its In.Pact Amphirion DCB for below-the-knee revascularization in patients with critical limb ischemia, based on forthcoming data from the company’s IN.PACT DEEP clinical study.
Researchers have been working for years to develop a reliable and cost-effective means of regenerating the hyaline cartilage found in the knee, with the aim of offering a minimally invasive treatment option for the millions of patients with painful knee osteoarthritis. Although this goal has been elusive so far, recent progress suggests the field may have turned a corner, and a large number of companies are now competing to win this quest, which many refer to as the “Holy Grail” of knee OA.
For therapeutic hypothermia device companies, the clinical trials that came before have been inconclusive, but they have provided insights to incorporate into the development of next-generation technologies. START-UP interviews two hypothermia device companies with novel approaches: Thermocure and ThermopeutiX.
Three years ago, Covidien signaled its intention to build a gastrointestinal device business with its acquisition of Barrx Medical and its esophageal ablation technology for Barrett’s esophagus. Since then, the industry has been waiting for Covidien to follow through on its strategy to expand its presence in the $3 billion GI market, and that next step came with the company’s recent $860 million acquisition of publicly traded Given Imaging Ltd.
Device manufacturers must declare compliance or explain noncompliance to good laboratory practice regulations for nonclinical studies in all premarket submission types, according to new draft guidance. This has not been the requirement for 510(k)s up until now, says the former CDRH 510(k) policy chief.
Investors and their limited partners really don’t like risk, especially not the kind due to uncertainty. Now, for developers of mobile health applications and their investors, at least one risk has been taken off the table: regulatory uncertainty. On September 23, the FDA published the much-anticipated final guidance on mobile medical apps.
Breathe Technologies is bringing a bit of disruption to the staid ventilator market: NIOV, a portable ventilator, can help patients breathe easier both inside and outside the hospital. But perhaps because innovation in this field isn’t common, the company is meeting resistance from some payors, most notably the Centers for Medicare and Medicaid Services, which doesn’t see the device as a ventilator but rather another form of oxygen therapy.
