The Latest
-
FDA 'white hat' hacking tools may combat medical misinformation
Cybersecurity techniques the agency uses to protect medical devices could also help fight the spread of medical misinformation, former FDA Commissioner Robert Califf wrote in a journal.
-
SponsoredDear medtech: I'm not sick, so why do you keep calling me a 'patient'?
With the entrance of consumer tech into the medtech industry, it's more important than ever to examine and evaluate clinical terms.
-
Margin for error 'almost zero' in testing pediatric devices
As barriers dog pediatric device development, one FDA-backed group is trying a different path.
-
Lloyd's exits notified body services, leaving UK with 3
The withdrawal comes as Europe faces major concerns about capacity ahead of the new MDR and IVD regs.
-
DHS warns of severe security flaw with BD infusion pumps
The department gave the BD Alaris Gateway Workstation vulnerability the maximum score on a standard grading scale.
-
Many in need of knee cartilage repair excluded from studies, researchers say
More inclusive clinical trial designs would better reflect the broader population needing treatment, study authors say.
-
AMA adopts measures to shape development, uptake of AI systems in healthcare
The policies seek to ensure developers of AI, not physicians, are liable for medical errors involving the technologies.
-
FDA issues draft advice on biotin interference with diagnostic testing
A 2017 agency safety communication reported a patient dying after high levels of biotin interference resulted in falsely low troponin results. Troponin tests are often used to detect heart attacks.
-
OIG estimates Medicare overpaid $269M for sleep studies
OIG thinks the problems occurred because CMS failed to provide the oversight needed to stop payments for noncompliant claims.
-
FDA posts draft guidance on testing of reproductive devices
The agency details how developers and manufacturers of assisted reproduction technology devices can perform mouse embryo assays to assess embryotoxicity.
-
Germany, Ireland push EU to assess device regs preparedness
The delegations think a significant reduction in notified bodies is likely but hope to avoid delaying implementation "unless absolutely necessary."
-
Device maker to pay $15M to resolve false claims allegations, 'silent recall'
ACell failed to report a product recall to FDA and billed Medicare for indications sales reps knew were not backed by clinical data to receive inflated reimbursement, the Department of Justice said.
-
China leads world in digital health adoption, Philips survey finds
Healthcare professionals in China are more likely to recommend patients use digital health technologies than their peers in the West.
-
Inhaler monitoring lowers COPD hospitalizations in small study
Cleveland Clinic researchers found that use of electronic inhaler monitoring together with a disease management program reduced healthcare utilization.
-
Antibiotic resistance test for gonorrhea gets FDA breakthrough nod
Australia's SpeeDx received the expedited review for a molecular test that detects both N. gonorrhea and a patient's susceptibility or resistance to the antibiotic ciprofloxacin.
-
Beta Bionics, Insulet seek shake-up of insulin delivery market at ADA
Data presented at the American Diabetes Association meeting move the companies a step closer to challenging Medtronic and Tandem.
-
Roche Diagnostics names Schinecker as new CEO
The appointment concludes a transitionary period for the company's diagnostic unit following the August exit of former CEO Roland Diggelmann, who served in the position for 10 years.
-
Pathology group sets expectations for DTC genetic tests
Amid a growing market for direct-to-consumer genetic tests, the Association for Molecular Pathology urged additional standards for test providers to meet.
-
EU names UDI issuers in move to new medtech regs
Four organizations will support implementation of UDI systems under the new EU Medical Device Regulation and In Vitro Diagnostics Regulation.
-
Quest, LabCorp breach stirs questions of cybersecurity risk from outside vendors
The breach could result in new regulations and rules governing how U.S. companies select and assess their vendors, according to Moody's.
UPDATED: June 11, 2019 at 10:49 a.m. -
Medtech avoids tariff blow as US, Mexico reach deal
President Donald Trump late Friday called off plans for a 5% tariff set to go into effect today on imports from Mexico.
-
Device interoperability, CGM for Type 2 patients among ADA 2019 standouts
Surprises at the American Diabetes Association's meeting included Medtronic's plan to market an interoperable insulin pump.
-
Stimulation device for IBS pain in children gains De Novo clearance
The non-invasive nerve stimulator is placed behind the patient’s ear to send electrical pulses to cranial nerve bundles.
-
Harvard's Wyss Institute receives $131M gift
The contribution comes from founder Hansjörg Wyss, the former CEO of Swiss device maker Synthes, whose vision for the institute has led to several medical breakthroughs over the past decade.
-
Concussion test gets breakthrough nod in fast-growing field
Brain Box's test diagnoses and rates the severity of traumatic brain injury, the incidence of which is on the rise.
