Ovarian Cancer Screen Faulted
The FDA is alerting women about the risks associated with diagnostic tests for ovarian cancer screening tests.
The agency said it was especially concerned that women who show no symptoms might delay effective preventive treatments but could still be at risk for ovarian cancer.
“Despite extensive research and published studies, there are currently no screening tests for ovarian cancer that are sensitive enough to reliably screen for ovarian cancer without a high number of inaccurate results,” the Sept. 7 safety notice said. Despite the lack of reliable tests, numerous companies market tests that claim to screen for and detect ovarian cancer.
Read the safety notice here: www.fdanews.com/09-08-16-FDAsafetynotice.pdf.
FDA Elevates Cook Recall to Class I
The FDA has elevated Cook Medical’s global recall of 8,750 units of its Roadrunner UniGlide hydrophilic wire guides as a Class I recall, the most serious type of recall.
Cook Medical announced the recall in August due to the possibility of glass particles in the coating of the wire guide units.
Cook requested customers and distributors to quarantine and discontinue use of all recalled units. For a full list of affected products and lot numbers, read the notice here: www.fdanews.com/09-07-16-Cookrecall.pdf.
Novo Nordisk Recalls GlucaGen HypoKits
The UK’s Medicines and Healthcare products Regulatory Agency issued a recall notice, warning that certain batches of Novo Nordisk’s GlucaGen HypoKits may be defective.
Novo Nordisk discovered a small percentage (0.006%) of needles that detached from the syringe in the GlucaGen HypoKit, making them unusable.
The affected lots were distributed between February and June 2016.
Similarly, Ireland’s Health Products Regulatory Authority (HPRA) determined that two batches of GlucaGen Hypokit and two batches of PCO Manufacturing GlucaGen Hypokit are being recalled in Ireland, which represents a total of 8,064 units.
Read the recall notice here: www.fdanews.com/09-07-16-MHRArecall.pdf.
Braun Gets FDA Nod for Xevonta Dialyzer
Braun Medical won FDA 510(k) clearance for its xevonta dialyzer, and it’s launching the next-generation filter in the U.S.
The new dialyzer features a filtration membrane designed to filter out smaller toxin molecules in patients’ blood while maintaining larger blood components.
Braun expects to offer the xevonta filter in September.
FDA Gives Green Light to Medtronic’s Enlite
The FDA approved Medtronic’s Enlite sensor for the iPro2 professional continuous glucose monitor. The device is a disposable sensor designed to be worn for six days and is 69 percent smaller than its previous sensor.
The iPro2 professional system is designed to track glucose levels every five minutes, continuously, for as long as six days to help doctors estimate the effectiveness of nutrition, medication and exercise programs. The iPro2 system gained FDA clearance back in November 2011.
FDA Grants EUA for Viracor-IBT Zika Dx
FDA issued an emergency use authorization to Viracor-IBT Laboratories’ Zika Virus Real-time RT-PCR test.
The in vitro diagnostic detects RNA from Zika virus in human serum, plasma or urine for patients showing clinical symptoms associated with the Zika virus.
The authorization is effective as of July 19. Read the EUA here: www.fdanews.com/09-07-16-EUA.pdf.
OrthoSera Receives CE Mark for hypACT
Austria-based orthobiologics company OrthoSera has received EU market authorization for its autologous hypACT injection device.
The company has developed a hyperacute serum technology to treat osteoarthritis and other degenerative diseases and is administered through the hypACT device.
The device isolates a specific serum derivative from the patient in a closed system, which is then applied during a same-day-procedure.