MPO’s Most-Read Stories This Week—June 18

Acquisition and approval news were online favorites this week, as two of MPO’s Top 30 companies announced deals and another received FDA product authorization.

Topping the Top 30-related items, however, was the U.S. Food and Drug Administration’s (FDA) 510(k) clearance of EarliTec’s EarliPoint Evaluation for autism spectrum disorder (ASD) for children aged 16-30 months. EarliPoint Evaluation is the first objective measurement tool to help clinicians diagnose and assess ASD, according to the company. Clinical data from two trials of more than 1,500 patients has shown the tool safely, consistently, and effectively delivers ASD diagnosis and measures the level of social disability and cognitive ability.

The other FDA clearance went to Johnson & Johnson Vision for its new AcuVue Oasys Max 1-Day and AcuVue Oasys Max q-Day Multifocal contact lenses. According to the company, the lenses help provide all-day comfort and visual clarity amid today’s modern lifestyles, long hours, and increased digital device use that take a toll on eye comfort. The new contact lenses—which also received both Health Canada and CE mark approvals—are available in spherical and multifocal configurations to address multiple vision correction needs. J&J Vision expects to launch them in the U.S., Canada, and multiple European countries in the fall. 

Boston Scientific and ResMed complemented and expanded their respective product portfolios through M&A. Boston Scientific entered an agreement with Synergy Innovation Co. to buy a majority stake (about 64 percent) in M.I.Tech Co., a Korean maker of endoscopic and urologic medical devices. M.I.Tech created HANAROSTENT, a family of conformable, non-vascular, self-expanding metal stents. Boston Scientific has been distributing the stents in Japan since 2015. The purchase price amounts to roughly $230 million.
 
ResMed, meanwhile, is acquiring MEDIFOX DAN, a privately held, German out-of-hospital software solutions provider, for about $1 billion. MEDIFOX DAN’s solutions include care documentation, personnel planning, administration, billing—similar to ResMed’s U.S. SaaS brands MatrixCare and Brightree. The deal builds on ResMed’s existing German business thanks to cloud-connected devices to transform care for sleep apnea or other respiratory patients.

Freudenberg Medical also drove traffic this past week with the announcement of its new CEO.

1. FDA OKs First Digital Health Tool to Diagnose, Assess Autism in Children

2. Freudenberg Medical Names Dr. Markk Ostwald as CEO

3. Boston Scientific Buys Majority Stake of M.I.Tech

4. FDA OKs J&J Vision’s AcuVue Oasys Max 1-Day Contact Lenses

5. ResMed to Acquire German Software Firm MEDIFOX DAN for $1B