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Digital health M&A flatlines in 2019, but IPO activity promising
Rock Health sees creation of remote patient monitoring reimbursement codes, progress on data blocking rules and FDA's Pre-Cert program as potential growth catalysts for the sector.
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Medtronic warns of Mazor X detachment issue in robotic surgery
In an urgent field safety notice, the medtech giant said one piece may detach from the OR table unexpectedly, which could lead to blunt injury to a patient.
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OrthoPediatrics sells Vilex assets in preparation for more M&A
The device maker sold the adult piece of the Vilex business, which it acquired last year, for $25 million.
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Simplified devices, pharmacy access among 2020 catalysts for diabetes tech: analysts
Baird Equity Research analysts expect this year will represent "an even greater technological leap forward than in 2018," previously thought to be the most significant new product launch year in more than a decade.
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Industry, doctors, patients diverge on FDA outline for breast implant labels
The Medical Device Manufacturers Association took issue with inclusion of the term "breast implant illness" and called a proposal that manufacturers continually update risk info "impracticable."
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Terumo subsidiary gains FDA nod for aneurysm flow diverter
MicroVention earned its third premarket approval in under two years. Stryker, Johnson & Johnson and Medtronic are also focused on treatments.
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Providers embrace loosening Stark Law regulations, suggest feds could go further
The Trump administration's proposed relaxation of regulations around the physician self-referral law has nearly unanimous support in both the hospital and physician community.
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Illumina scraps $1.2B PacBio takeover amid regulatory pushback
Cowen analysts listed Agilent, Danaher and Thermo Fisher as potential buyers of Pacific Biosciences.
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CMS delays clinical lab fee schedule data reporting, cuts capped at 15% for 2021
The decision to maintain the status quo comes despite labs hoping the agency would freeze rate cuts next year.
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NuVasive replaces CFO with former Mallinckrodt executive
The company sought to allay concerns arising from the C-suite change by reiterating its expectation that 2019 revenues will total $1.16 billion.
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FTC slaps Stryker, Wright Medical with second request
The review doesn't come entirely as a surprise. A Stryker executive told analysts on a Nov. 4 conference call the company anticipated some level of antitrust review in estimating a third quarter of 2020 target for the deal to close.
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FDA finalizes exemptions for certain devices from 510(k) review
Newly exempted devices are still subject to other regulatory controls, such as good manufacturing practice requirements.
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Notified bodies MedCert, BSI gain new EU MDR and IVDR designations
The European Commission's latest nods bring total notified bodies designated for the Medical Device Regulation to nine and for the In Vitro Diagnostic Regulation to three.
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Myriad wins FDA nod for Lynparza companion diagnostic
The test is meant to identify metastatic pancreatic cancer patients with a germline BRCA mutation who are candidates for AstraZeneca and Merck's pill, the second targeted treatment approved for pancreatic cancer.
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FDA creates best practices for combination product developers
The 21st Century Cures Act requires the agency to provide final guidance on aspects of the submission process including how companies should obtain feedback.
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Roundup 2019: Breast implants, mesh, paclitaxel-coated devices among hot topics at FDA expert panels
The public meetings in some cases instigated voluntary recalls and led to required market removals. Nearly all called for further research or more robust medical device monitoring.
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Hologic unloads underperforming Cynosure medical aesthetics unit
"This divestiture was a long time coming and puts an end to a bad marriage," William Blair analyst Brian Weinstein said of Hologic's $1.6 billion deal in 2017. Now, the company expects $138 million in cash proceeds from its sale.
UPDATED: Dec. 30, 2019 at 2:40 p.m. -
Medical device tax disappears, capping decade of industry lobbying
President Donald Trump signed a spending package into law Friday, permanently repealing the ACA tax. The device industry garnered bipartisan backing to nix the 2.3% levy.
UPDATED: Dec. 23, 2019 at 10:18 a.m. -
Medtech manufacturing lags pharma in emerging markets, McKinsey report says
Due to growth through acquisitions, many medtech companies find themselves wrestling with costly, fragmented manufacturing and distribution footprints in need of an overhaul, a new McKinsey analysis suggests.
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LivaNova recalls vagus nerve implant amid reset problems
FDA received 14 reports of an error causing the device to stop delivering treatment for major depressive episodes and seizures associated with epilepsy. Four patients have needed revision surgery as a result.
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J&J takes over Verb Surgical as Verily exits robotics partnership
The move comes four years after J&J launched the venture with Google-backed Verily, further signaling the medtech giant's play for the digital surgery market after its $3.4 billion acquisition of Auris Health.
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Wright Medical filings, report hint of rivals to Stryker's $5.4B acquisition
Regulatory filings show as many as five parties besides Stryker, which agreed to pay $30.75 per share, were interested in bidding for Wright.
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FDA downclassifies cranial electrotherapy stimulators for anxiety, insomnia
But the agency will still require premarket approval for the devices when intended to treat depression.
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Delaware court deals blow to Boston Scientific in Channel Medsystems lawsuit
Boston Scientific's attempt to terminate its $275 million acquisition of cryoablation device maker Channel Medsystems was ruled inappropriate by the Delaware Court of Chancery Wednesday.
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Fujifilm to acquire Hitachi's diagnostic imaging arm for $1.63B
With new capabilities in CT, MRI and ultrasound, Fujifilm will look to compete more fiercely with global players like Siemens, GE, Philips and Canon.
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