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. FDA wants more from Proteus, Otsuka on ‘smart pill’
Otsuka Pharmaceutical and Proteus Digital Health said today that the FDA issued a complete response letter requesting more information from the companies for the combination of the Proteus “smart pill” and Otsuka’s Abilify anti-depressant drug.
The Proteus pill is designed to signal a wearable patch after it reaches the stomach, recording and time-stamping data from the pill and other patient metrics. The data can be relayed via Bluetooth to mobile devices and, with consent, to healthcare providers. Read more
4. Boston Scientific chides EU docs for unsupervised Lotus valve implants
Boston Scientific today released a field safety notice warning after an investigation identified that a “number of sites” had been performing procedures with the Lotus Valve System without an appropriately trained field clinical specialist.
The Marlborough, Mass.-based company said that the presence of a Boston Scientific field clinical specialist is required unless a site is designated as “independent” by the company. Independent site designation requires 2 physicians undergo face-to-face training, perform a minimum of 6 lotus valve procedures with a proctor and an additional 4 valve implants with FCS supervision. Read more
3. Edwards Lifesciences boosts outlook after Street-beating Q1
Edwards Lifesciences yesterday boosted its outlook after posting 1st-quarter numbers that beat expectations on Wall Street, with CEO Mike Mussallem saying the FDA could approve an intermediate-risk indication for its Sapien 3 heart valve this year.
The Irvine, Calif.-based company reported profits of $143.0 million, or 66¢ per share, on sales of $697.3 million for the 3 months ended March 31, marking a 15.9% bottom-line gain on sales growth of 18.1% compared with Q1 2015. Adjusted to exclude 1-time items, earnings per share were 71¢, ahead of the Street’s forecast for 66¢. Read more
2. Synergy, Watchman help Boston Scientific swing to Q1 black
Boston Scientific reaped the rewards of its turnaround push today with a 1st-quarter swing to black ink, raising its outlook for the rest of the year, helped by contributions from its Synergy and Watchman devices.
Investors reacted by sending BSX shares up 6.0% to $20.85 in pre-market trading this morning. Read more
1. Stryker blasts DJO Global, ex-reps in poaching lawsuit
Stryker this week blasted orthopedics rival DJO Global in a poaching lawsuit claiming that DJO and a quintet of ex-sales reps gutted its Indiana sales territory and are looking to lure more of the former Stryker colleagues into leaving.
The lawsuit aims “to stop the targeted raiding of its employees by its direct competitor DJO Global, in concert with several former Stryker employees,” Kalamazoo-Mich.-based Stryker said in the April 25 complaint. The suit alleges 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 its ortho & trauma sales in Indiana last year. Read more
The post MassDevice.com +5 | The top 5 medtech stories for April 27, 2016 appeared first on MassDevice.
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