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. EU Council & Parliamentary councils signs off on new med device, IVD regs
The Environment, Public Health and Food Safety Committee of the European Parliament and Council’s Committee of Permanent Representatives voted yesterday to endorse new medical device and in vitro diagnostic regulations, according to MedTech Europe.
The approval paves the way for for the adoption of 2 new draft regulations by the end of 2016, though the new rules would not take effect for 3 years in relation to medical devices and 5 years for IVD. Read more
4. EndoGastric Solutions wins nod from medical society for Esophyx anti-GERD device
The American Gastroenterological Assn. recommended that insurers cover the Esophyx device for treating gastroesophageal reflux disease made by EndoGastric Solutions.
Citing the data from a quartet of randomized, controlled trials, the AGA said transoral incisionless fundiplication with Esophyx ought to be reimbursed for the 20% to 40% of GERD patients who don’t respond to medication. Read more
3. FDA OKs epilepsy trial for MDT’s Visualase MRI-guided laser
Medtronic said today that the FDA granted an investigational device exemption for a clinical trial of its Visualase ablation device in treating temporal lobe epilepsy.
Fridley, Minn.-based Medtronic put $105 million on the table for Houston-based Visualase back in 2014, including $70 million in up-front cash and another $35 million in milestones. Medtronic had a stake in Visualase and its MRI-guided laser ablation device. Read more
2. OrthoPediatrics registers $75m IPO
OrthoPediatrics, which says it is the only medical device company exclusively devoted to orthopedic implants for children, this week registered for an initial public offering worth $75 million.
Based in the orthopedics hotbed of Warsaw, Ind., OrthoPediatrics plans to list on the NASDAQ exchange under the “KIDS” symbol. The company counts Squadron Capital among its backers. Read more
1. DJO Global, ex-Stryker reps want poaching case tossed
DJO Global and a quintet of ex-Stryker sales reps want federal judge to toss Stryker’s lawsuit claiming that DJO and the reps gutted its Indiana sales territory and are looking to lure more of the former Stryker colleagues into leaving.
The April suit in the U.S. District Court for New Jersey alleged that the scheme by DJO and a quintet of former Stryker sales reps – Kywin Supernaw, Brad Bolinger, Justin Davis, Jake Eisterhold, Eric Huebner and Tim Broecker – took a roughly 33% bite out of Stryker’s ortho & trauma sales in Indiana last year. Read more
