Warsaw, Ind.-based Orthopediatrics Corp. is scooping up Apifix Ltd., allowing it to gain the Minimally Invasive Deformity Correction (MID-C) system, which is used to treat adolescent idiopathic scoliosis. BTIG’s Ryan Zimmerman noted that the deal has a potential value of $67 million plus potential future revenue milestones. “The initial upfront payment has a ~$37 [million] value, composed of $2 million in cash and ~935k shares of common stock,” he added. Read More
With the COVID-19 pandemic overwhelming hospitals and treatment centers, San Jose, Calif.-based Outset Medical Inc. scored a big win with U.S. FDA clearance of its Tablo hemodialysis system for home dialysis use. The company will begin rolling the system out for home patients in the coming months, balancing that program with demand for onsite devices to support an upswell in COVID-driven dialysis treatments. Read More
The novel coronavirus pandemic has been managed with widely varying degrees of success around the world. Artificial intelligence (AI), which can help to power all sorts of efforts, has been enlisted thus far in limited ways. But researchers at a virtual conference held on April 1 by the Stanford Institute for Human-Centered Artificial Intelligence explored some of the ongoing and potential applications of AI to systematize efforts to fight COVID-19. Read More
BEIJING – After its masks and test kits were said to be sent back by Western countries due to complaints over poor quality, China this week required only NMPA-approved companies export their products and stepped up regulations to ensure quality. Read More
The U.S. Patent Trial and Appeal Board (PTAB) determined it would not take an inter partes review petitioned by Advanced Bionics Inc., in a patent dispute with Med-El Elektromedizinische. The precedential PTAB decision notes that it had invoked a two-step process for declining to take the petition as seen in a patent dispute involving Becton Dickinson and Co., and affirming that this will be the standard for addressing prior art in such appeals going forward. Read More
Given the evolving COVID-19 situation, U.S. House committee chairs are asking the White House Office of Management and Budget (OMB) to direct federal agencies to immediately extend all public comment periods by at least 45 days beyond the end of the declared national emergency, whenever that may be. Read More
New hires and promotions in the med-tech industry, including: Castle Biosciences, Curvafix, E-therapeutics, Invo Bioscience, Nexgel, Sera Prognostics. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allergan, Braintale, Outset Medical, Orthopediatrics, Royal Philips, Sectra, Tissium, Won Tech. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Cellex, Ipsum Diagnostics, Refocus Group. Read More
Keeping you up to date on recent developments in diagnostics, including: Tracking heart function with AI; Localizing arrhythmia; Wearables not yet ready for prime time; A20s inflammation-fighting properties decoded. Read More
