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‘Indomitable Spirit’ Spurs Incontinence Treatment Firm Axena
Axena Health recently secured a HCPCS code for its female incontinence device Leva. For CEO Eileen Maus, this is just the latest in a string of successes across the women’s health, or femtech, sector.
News We’re Watching: New Cybersecurity Standard; CMS Prodded On TCET; Olympus Scopes Recalled
This week, NIST published a new version of its international cybersecurity standard; SeaStar Medical’s kidney device got an HDE; and the FDA announced safety issues for DT MedTech LLC, operating room tables, and GE incubators.
DOJ: False Claims Settlements Neared $2.7Bn In 2023
The government collected $2.68bn from settled False Claims Act cases last year, the US Department of Justice said. Another 12 device-related cases were announced in February alone.
NICE Recommends Endoscopic Sleeve Gastroplasty To Treat Obesity
NICE has recommended endoscopic sleeve gastroplasty for the treatment of obesity in adults.
SVB’s Milo Bissin Predicts ‘Reckoning In 2024’ For Health Care Companies With Sky-High Valuations
VC funding will remain challenging for many in the health care industry, Silicon Valley Bank’s market manager Milo Bissin told attendees at the recent DHIS West conference. Companies focusing on promising areas such as AI-powered technologies, women’s health and value-based care likely have the best chances to draw investors’ attention.
UK Offers £10M Funding To Eight Medtech Innovators
The Innovative Device Access Pathway pilot has launched in the UK with eight new promising medical technologies. The cohort is overwhelmingly diagnostic-focused, with innovative testing for Alzheimer’s, stroke, and liver cancer, amongst others.
$2Bn Hike In Catheter Billings Could Point To Fraud
The US government is said to be investigating a sudden spike in Medicare billings for urinary catheters, which jumped from $153m in 2021 to $2.1bn in 2023.
Progress Made With HTA Regulation Implementation Plan
Implementing acts for Joint Clinical Assessments and exchange of information with the EMA were on the agenda of this month’s Member States Coordination Group on HTA meeting. The discussion marks considerable progress towards the application deadline in January 2025.
News We’re Watching: AdvaMed Lobbies On Innovation Bill, Prison Time For 510(k) Forger, Neuralink Fined For Hazardous Materials Violations
This week, AdvaMed prodded Congress to act on an innovation tax credit bill; two Senators introduced a bill aimed at improving device accessibility for the blind; and Cepheid got a CLIA waiver.
Dexcom COO On Stelo CGM Plans, Apple Watch Developments, And Why Non-Invasive Glucose Monitoring Still Leaves Much To Desire
Exec Chat: Dexcom’s COO Jake Leach joined a panel discussion on the future of biosensing at CES 2024, where biowearables and glucose tech ranked among hot topics. He also spoke to Medtech Insight about plans for the company’s new CGM called Stelo, designed for people with type 2 diabetes who do not use insulin, Dexcom’s work with Apple to enable CGM users, and non-invasive monitoring prospects.
2024 Radar: UK Medtechs Up The Pace On Sustainability And Assess AI Potential
Three UK medtech companies’ views on how their businesses will be influenced by external factors in the coming year.
UK NHS Will Not Fund 'Artificial Pancreas' Unless Companies Lower Prices
NICE, the UK’s health technology assessment organization, recommends hybrid closed loop systems for hundreds of thousands of people living with type 1 diabetes. Funding, however, is subject to companies agreeing to lower their systems’ price.
CMS-FDA Joint Statement Backs LDT Regulation
The statement says that CMS supports a proposal that would impose FDA regulatory requirements on lab-developed tests to help ensure patient safety.
Arik Ishay Is Marching To The Biobeat Of His Own Drum
Biobeat defies the usual trend of start-ups seeking ever-growing sums of capital before either going public or being acquired. Its CEO, Arik Ben Ishay, believes the company can quickly become self-sufficient by tackling endemic problems.
Experts: Watch For FCA Scrutiny On Debt Forgiveness, Free Repairs
Attorneys discussing likely False Claims Act trends for 2024 at a recent conference said they have seen more cases involving alleged kickbacks in the form of debt forgiveness and free repairs. They also expected an increase in off-label marketing and cybersecurity cases in the new year.
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