FDA promotes its Case for Quality initiative amid a slew of pilot programs to improve plant inspections
The FDA is pushing device manufacturers to go beyond meeting baseline regulatory guidelines through its Case for Quality initiative, the head of the FDA's device arm (CDRH), Dr. Jeffrey Shuren, wrote in a post on the agency's blog.
The U.S. military has awarded a $14.3 million contract to Pryor Medical Devices to conduct a clinical trial to support an FDA clearance of its balloon catheter to temporarily occlude large vessels and monitor blood pressure in a trauma emergency without the use of fluoroscopy. That would enable its use on the battlefield to more effectively treat noncompressible torso hemorrhages, which are the top cause of potentially survivable death in combat.
As researchers explore innovative tools for diabetes monitoring, scientists in Mexico are developing a smartphone-based device that can measure glucose in the blood by analyzing urine in the toilet.
By installing replicas of medical devices at more than 60 hospitals, cybersecurity firm TrapX Security has demonstrated the presence of shadowy groups who are hacking devices to steal valuable personal medical information and sell it on the black market, Bloomberg reports.
GE Healthcare will work with Oregon Health & Science University to develop collaborative research programs in cardiovascular medicine, imaging and big data research. They expect to address essential questions about biology and medicine through the combination of the clinical expertise of OHSU and the technological facility of GE Healthcare.
Companies are developing innovative devices for medical marijuana, rolling out everything from palm-sized inhalers to metered products that deliver drugs through the inner cheek. Massachusetts startup CannaKorp is taking a different approach, creating a Keurig-like medical marijuana vaporizer device to compete for its share in a growing market.
Optical coherence tomography player Optovue has nabbed a $30 million investment from the Dutch subsidiary of Delta Electronics. The financing is expected to help back its existing OCT and OCT angiography products as well as its latest AngioVue Imaging System.
Chicago-based healthcare company incubator Matter just opened a 450-square-foot mock physician office in partnership with the American Medical Association.
Blood glucose monitor manufacturers are working to make their data easily accessible and analyzable by patients and healthcare providers. But that's a tall order for this industry segment, which has historically been focused on making tracking easier, cheaper and more convenient rather than more useful.
In a sure sign of recovery from a famous setback dealt by the FDA, Anne Wojcicki promised she will not sell her once again trendy diagnostics company 23andMe.
Almost one million childhood deaths are attributed to pneumonia annually, leading UNICEF to issue a call in 2011 for product innovation to create a respiratory monitor. Now, Royal Philips is almost ready to launch its Children's Automated Respiration Monitor that is designed to address those needs.
Myriad presents studies showing that its rheumatoid arthritis test can predict patient response to drugs
Myriad Genetics touted three studies at the meeting of the American College of Rheumatology in San Francisco showing that its Vectra DA diagnostic for measuring the severity of rheumatoid arthritis can help guide patient selection for biologic or nonbiologic drugs by predicting their response to the various therapies and treatment strategies.
Apple has dealt with setbacks for its Apple Watch since rolling out the product earlier this year, shelving certain health features prior to launch and facing complaints over the accuracy of the device's heart rate monitor. With its med tech aspirations for the watch on the backburner, some analysts think the company could turn to corporate markets to boost sales for the product.
Dx Digest: Quest snatches up lab service business; Circulogene Theranostics rolls out finger-stick liquid biopsy tests
In this week's Dx Digest, sepsis test maker T2 Biosystems revealed promising study results for its bacteria panel, lab giant Quest Diagnostics snatched up Clinical Laboratory Partners' outreach laboratory service business to expand its testing footprint, and Circulogene Theranostics launched cell-free DNA tests for cancer monitoring.
Ameera Shah is founder of India's Metropolis Healthcare, a diagnostics company focused on that fast-growing economy, as well as some African countries.
A study published in the New England Journal of Medicine found that mitral valve replacement results in a lower rate of heart failure and fewer hospitalizations for cardiovascular complications at two years after surgery.
Radiopharmaceutical diagnostics company Advanced Accelerator Applications gained about 25%, or $4, in early trading after pricing an IPO on Nov. 10. That makes it at least the third U.S. med tech IPO since mid-September. Med tech IPOs continue to fare well despite a rocky broader market; the two prior ones for NovoCure and Penumbra remain up by 10% and 34%, respectively.
AliveCor has been an early winner in the quest for digital consumer health devices. Its FDA-cleared ECG monitor that wirelessly connects to smart devices has been used to record more than 4 million ECGs since it was first green-lighted by the agency in December 2012. Now, the startup is aiming to begin its consumer expansion efforts in earnest with the addition of a new CEO--former Google executive Vic Gundotra.
Boston Scientific's stroke-preventing Watchman was just hit by bad news on multiple fronts. The FDA revealed that the Watchman is the subject of two Class 2 recalls, while the Centers for Medicare & Medicaid Services has just deemed reimbursement of the device "not reasonable and necessary."
The fallout over Theranos' proprietary blood testing has cost it another partner amid growing pushback, as grocery store giant Safeway is severing its ties with the company after a $350 million deal fizzled out.