The Latest
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Apple EKG, artificial iris among FDA 2018 device decisions
De Novos are on the rise, but both premarket approvals and 510(k)s appear to be slightly down from 2017, according to nearly year-end data from FDA.
Medical Devices -
FDA touts progress in move toward global device audits
Participating manufacturing sites have spiked this year with 2,629 cumulatively added as of the third quarter of 2018, up from 777 at the end of 2017.
Medical Devices -
FDA adds information on device BLAs to user fee guidance
The revised document features additional information on the fees for device biologics license applications.
Medical Devices -
FDA rates GE ventilator safety guard recall as Class I event
The recall was triggered after the tech giant discovered the device has the potential to disconnect from the patient's breathing circuit.
Medical Devices -
Grand jury indicts physician over alleged medical testing fraud
The indictment came days before the government settled a separate fraud case with an audiology practice.
Legal -
Merck taps Roche for Keytruda companion diagnostic
Roche will develop a test to identify patients with a certain biomarker known to make solid tumors vulnerable to treatment with the checkpoint inhibitor.
Diagnostics -
Boston Scientific scores US victory in TAVR patents battle
A jury in the U.S. District Court for Delaware determined that the Sapien 3 device from Edwards Lifesciences infringed a Boston Scientific patent in the hotly contested transcatheter aortic valve replacement systems market.
Medical Devices -
UK readies 'worst-case' Brexit plan for medical devices
The government issued an update on its contingency planning if no deal is reached by March 29 for the country to remain part of the EU medicines and medical devices regulatory networks.
Medical Devices -
Australia plans reclassification of medical software to better reflect risk
The country's regulator thinks the current system underestimates the threat posed by software as a medical device.
Policy & Regulation -
HIMSS: Health coaching could boost value of wearables
HIMSS surveyed 101 health IT and hospital administrators for the Fitbit-sponsored report, which found that half of hospitals and health systems were already implementing health coaching, or planned to do so.
Medical Devices -
Lawmakers impatient for ONC interoperability rule
"It is hard to explain to people that Congress provided the tools necessary for doctors and patients to better coordinate their care through the sharing of patient data, but nothing has changed," Rep. Michael Burgess, R-Texas, said at a House health subcommittee hearing.
Policy & Regulation -
Duodenoscope studies find higher-than-expected contamination rate, FDA says
Across studies run by Olympus, Fujifilm and Pentax, 6% of sampled devices were contaminated with microorganisms including pathogenic strains such as E. coli.
Medical Devices -
Pear's digital treatment for opioid abuse gets FDA nod
The app is a medication-assisted treatment that provides cognitive behavioral therapy to increase care retention rates for adults with opioid use disorder.
Digital Health -
Thermo Fisher gets FDA nod for plazomicin immunoassay
The antibiotic, marketed as Zemdri, is used to treat patients with complicated urinary tract infections.
Policy & Regulation -
Hospital beds from Hill-Rom get sensor tech
Sensors continually check patients' heart and respiratory rates and alert providers if their vital signs change.
Medical Devices -
Hologic begins selling 3-in-1 uterine scope
The device is intended to improve the procedure for treating uterine conditions by avoiding the need to change from a diagnostic to an operative scope.
Medical Devices -
Allscripts to sell stake in Netsmart for $525M
The EHR vendor said the sale will allow it to pay back long-term debt and invest in other areas.
M&A -
FDA to revisit transvaginal mesh issues at February meeting
The agency said it may consider additional regulatory actions based on public feedback and Feb. 12 advisory panel discussions.
Medical Devices -
Cybersecurity priorities laid out by key House panel
The House Energy and Commerce Committee issued a report outlining six strategies for strengthening the nation's defenses against cybersecurity vulnerabilities with a focus on medical devices in healthcare.
Medical Devices -
No single telehealth vendor meeting all customer needs, KLAS says
Recent consolidations within the sector, however, could aid the effort to achieve all-purpose telehealth vendors, according to the report.
Digital Health -
FDA clears Contego Medical peripheral angioplasty system
The catheter-based device for use in procedures to treat peripheral artery disease incorporates an adjustable filter to capture blood clots and is intended for high-risk patients.
Medical Devices -
FDA guide unveils vision for cancer diagnostics
The proposal came the same day lawmakers released an updated draft bill that would grant FDA authority to oversee in vitro clinical tests, such as test kits and laboratory developed tests.
Policy & Regulation -
Device industry 2019 outlook beats hospitals, pharma: Moody's
The credit ratings agency said the sector will benefit from new product innovation and demand from emerging markets, but could face headwinds from rising trade tensions and the reinstatement of the medical device tax in 2020.
Medical Devices -
Dive AwardsThe MedTech Dive Awards of 2018
The awards recognize the industry's top disruptors and newsmakers. These officials and companies are shaking up the medical technology sector and shaping the future.
Medical Devices -
Edwards expects TAVR demand to fuel double-digit growth in 2019
The company predicts 11% to 15% TAVR growth for the second year in a row.
Medical Devices