Philips will pay at least $613 million to settle economic lawsuits related to its recall of millions of CPAPs and other respiratory devices. U.S. District Court Judge Joy Flowers Conti, who has been overseeing the multidistrict litigation out of her court in Western Pennsylvania, approved the final settlement yesterday. “The amount of value created and […]
How Philips’ significant respiratory devices recall unfolded
There are 5.5 million recalled CPAPs and other devices — and reports of deaths. Here’s a Philips recall timeline. Philips in mid-2021 kicked off a recall that involved millions of CPAP and BiPAP ventilators and other respiratory devices. The devices — used for sleep apnea therapy and more — had sound abatement foam that could […]
Boston Scientific has a serious recall involving embolization tech
The FDA announced today that it has designated a Boston Scientific recall of its Obsidio conformable embolic as Class I, its most serious level of recall. The Obsidio embolic is a premixed embolic agent that is delivered in a minimally invasive way through a catheter-based system to block or occlude blood flow to specific blood […]
Shockwave Medical is reportedly a J&J acquisition target
Shockwave Medical could get acquired by Johnson & Johnson , according to a Wall Street Journal report. WSJ cited people familiar with the matter. They said the acquisition talks, if successful, could result in a finalized deal in the coming weeks. Another suitor could also seek a merger with Santa Clara, California–based Shockwave. The WSJ […]
Intuitive wins FDA clearance for its next-gen da Vinci 5
Intuitive Surgical has secured FDA 510(k) clearance for its next-generation da Vinci 5 multiport surgical robotics system. The news, announced yesterday after market close, comes less than two months after the dominant surgical robotics developer disclosed that it had submitted for the much-anticipated clearance, revealing the name of the new system in the process. (Here […]
What’s next for orthopedic device tech? Enovis’ CEO has ideas
“We’re excited about the momentum we’re building. We think we’ve made a good initial splash here,” Enovis CEO Matt Trerotola recently told MassDevice. One of the largest orthopedic device companies in the world, Wilmington, Delaware–based Enovis has had a string of positive news lately: Financial results swung to a profit as part of Street-beating fourth […]
Medtronic has a serious catheter tubing recall
The FDA today designated a Medtronic recall of Duet external drainage and monitoring system catheter tubing as Class I, its most serious level. Medtronic Neurosurgery initiated the recall on Jan. 22. According to the FDA, it involves 45,176 devices distributed from May 3, 2021, to Jan. 9, 2024. The model numbers involved are 46913, 46914, […]
Natus Neuro taps Philips, Medtronic veteran as CEO
Natus Medical (Middleton, Wisconsin) recently announced that a well-known executive in the Minneapolis-St. Paul medical device hub is the new CEO of its Natus Neuro business. Chris Landon joined Natus last month after serving for four years as the president and GM of Image Guided Therapy Devices at Philips. Before Philips, Landon worked at Medtronic […]
Baxter is closing Massachusetts facility
Baxter will shutter its manufacturing facility in Acton, Massachusetts. In a statement shared with MassDevice, the company said: “We made the difficult decision to close manufacturing operations at our Acton location. We are moving these operations to another facility within Baxter’s integrated supply chain network. We appreciate our Acton-based colleagues’ dedication and service and are […]
Medtronic may face jury trial in spine implants case
A nearly decade-old whistleblower suit against Medtronic — involving FDA clearance of spine fusion devices — is moving forward. In an order dated Feb. 16, U.S. District Court Judge John Kronstadt in Central California denied Medtronic’s motion for summary judgment in the case filed by The Dan Abrams Co. LLC. The LLC’s sole employee, Bryan […]
Orthofix announces new president of Bone Growth Therapies
Orthofix Medical (NASDAQ:OFIX) is promoting from within to fill a new business president position at the company. The Lewisville, Texax–base spine and ortho tech company announced today that it moving its Bone Growth Therapies business out from under the leadership of its Spine business. Jason Shallenberger, previously the VP of U.S. sales and marketing for […]