Approvals

FDA Grants EAP Designation to AngioDynamics Cancer Treatment System

New York-based devicemaker AngioDynamics obtained the FDA’s expedited access pathway designation for its NanoKnife ablation system for treatment of Stage III pancreatic cancer.

NanoKnife is designed to permanently open pores in targeted cell membranes via low energy direct current electrical pulses, resulting in cell death, and the patient’s body naturally removes the treated tissue “in a matter of weeks,” the company said.

The system previously received 510(k) clearance for surgical ablation of soft tissue.

Bio-Rad Gains Additional FDA Clearances for Blood Typing Products

Bio-Rad Laboratories received 510(k) clearance from the FDA for its IH-Incubator L and IH-Centrifuge L instruments for use with the full range of Bio-Rad’s IH-system gel reagents for manual blood typing methods.

The instruments maximize efficiency and space in the laboratory by accommodating both conventional tube and gel blood typing.

“This addition rounds out our offering, specifically benefitting smaller laboratories that use manual methods to test blood,” said John Hertia, Bio-Rad’s executive vice president and president of the company’s clinical diagnostics group.

electroCore Snags New Use Indication for Portable Migraine Therapy Technology

Bioelectronic medicine company electroCore achieved FDA 510(k) clearance for a new use indication on its gammaCore therapy technology.

The new clearance allows for the noninvasive neuromodulation treatment to be used for treating acute migraine-associated pain in adult patients. The FDA previously cleared gammaCore for treating pain associated with adult episodic cluster headache.

Self-administered treatment, using gammaCore, can be delivered through a hand-held unit designed to provide mild electric stimulations to the vagus nerves through a patient’s skin.

FDA Clears Masimo Brain Function Monitoring Device

The FDA cleared the Next Generation SedLine brain function monitoring device from Masimo.

“SedLine helps clinicians monitor the state of the brain under anesthesia with bilateral acquisition and processing of four lead of electroencephalogram (ECG) signals,” Masimo said.

The device uses a signal processing engine for providing clinicians with a complete picture of a patient’s brain representing activity in both sides.

Meso Scale Diagnostics Wins FDA Nod for IVD Assay

Maryland-based immunoassay developer Meso Scale Diagnostics received FDA clearance for its conventional C-reactive protein assay for in vitro diagnostic use.

The assay features the company’s proprietary multi-array technology and its MESO SECTOR S 700 for the detection of analytes in bodily fluids.

Multi Radiance Medical Pain Relief Laser Technology Achieves FDA Clearance

Multi Radiance Medical achieved FDA clearance for its MR4 Laser technology indicated for neck and shoulder pain relief.

The technology was cleared under the Product Classification NHN.

The new classification “gives clinicians and patients a clinically proven safe and effective alternative to opioids and other drugs for managing this common pain,” the company said.

FDA Clears Campylobacter Assays

The FDA cleared two diagnostic tests manufactured by TECHLAB for diagnosing campylobacteriosis, a foodborne illness that causes diarrhea, cramps, fever, and vomiting.

The CAMPYLOBACTER QUIK CHECK can detect Campylobacter jejuni and Campylobacter coli in less than 30 minutes, the company said.

The CAMPYLOBACTER CHECK is designed to aid diagnostic laboratories in testing large numbers of human fecal specimens.

Visioneering Technologies Suite of Contact Lenses Gets CE Mark

Atlanta-based devicemaker Visioneering Technologies received a CE Mark for its suite of proprietary NaturalVue contact lenses.

The lenses use Visioneering’s Neurofocus optics technology for an “extended depth-of-focus design to address known optical risk factors associated with myopia progression.”