Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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5. Vertos Medical raises $28m for Mild spine treatment
Vertos Medical said yesterday that it closed a $28 million financing round for its Mild treatment for lumbar spinal stenosis.
The round was led by new investor MVM Life Science Partners, joined by prior backers Leerink Revelation Partners, Pitango Venture Capital, ONSET Ventures and Aweida Venture Partners. MVM partner Hugo Harrod is joining the Vertos board as part of the transaction, according to a press release. Read more
4. Olympus settles power morcellator suit
An Olympus subsidiary agreed to settle a lawsuit filed over the power laparoscopic morcellator used in a gynecological surgery.
Plaintiffs Betty and Elvis Dobson alleged that the Olympus KS PlasmaSORD used in Betty’s 2010 hysterectomy spread myxoid leiomyosarcoma cells in her abdomen and pelvis. Power morcellators use small, rotating blades to break up large tissue masses into fragments and are commonly used to remove benign uterine fibroids in women. Although the FDA approved morcellators in 1995, it wasn’t until 2013 that the late Dr. Amy Reed exposed the risk after undergoing a hysterectomy at the Boston hospital where she worked as an anesthesiologist. Read more
3. Cleveland Clinic spinout Infuseon wins FDA nod for CNS drug delivery device
Cleveland Clinic spinout Infuseon Therapeutics said today that its novel central nervous system delivery device won 510(k) clearance from the FDA as a therapeutic delivery device.
The company’s Cleveland Multiport Catheter, which won FDA clearance in March, was designed to effectively deliver therapeutics to the brain. Usually, the blood brain barrier prevents drugs delivered in traditional methods from reaching their target. Read more
2. Invuity recalls PhotonBlade
Invuity said today that it recalled its PhotonBlade minimally invasive surgery light, after a few customers reported “unintended energy discharge” during procedures.
The PhotonBlade device, which won 510(k) clearance from the FDA in August 2016, was in a limited market release that began in March, Invuity said. Customer feedback, gathered to inform improvements to the device, also delivered the unintentional energy release issue “with the potential to cause tissue damage to patients,” the San Francisco-based company said. Read more
1. FDA lifts warning letter on Zimmer Biomet plant in China
Zimmer Biomet said today that the FDA closed out a 2015 warning letter over problems at a subsidiary’s plant in China.
The June 3, 2015 letter flagged 5 violations found during inspections of the Zhejiang Biomet Medical Products plant in Jinhua City, Zhejiang, following inspections of January of that year. Read more
