February 1, 2019

FDA Clears Verily’s ECG Device

Alphabet subsidiary Verily’s Study Watch received 510(k) clearance for its electrocardiogram feature, allowing the device to record a patient’s ECG rhythms.

The wearable device can store, transfer and display single-channel ECG rhythms and is indicated for use by healthcare professionals, health conscious patients and adults with heart conditions.

The device enables the scalable collection of data in clinical and observational studies. It has previously been used in clinical trials to capture participants’ health information.

Biom’up’s Laparoscopic Applicator Earns New Marketing Approval

The FDA granted Biom’up’s Hemoblast Bellows laparoscopic applicator marketing approval for all minimally-invasive procedures.

The approval expands the device’s indications and allows surgeons to use the hemostatic powder in both traditional and laparoscopic surgeries.

The device is used to quickly deliver Hemoblast powder to bleeding areas in minimally-invasive surgeries, providing control of minimal, mild and moderate blood flows.

FDA Clears RFPi’s Blood Flow Imaging Device

The FDA granted 510(k) clearance for RFPi’s iCertainty, a non-invasive blood flow and perfusion imaging device for use in surgical procedures.

The device shows a patient’s blood flow without interrupting surgery or requiring dyes, radiation, injections or direct patient contact.

The product is cleared for imaging blood flow and perfusion in tissue up to 4-5mm in depth. It’s initial uses include lower-leg vascular procedures and gastrointestinal and plastic surgeries.

Tivic Health’s Sinus Pain Reliever Device Cleared

Tivic Health received 510(k) clearance for its ClearUP bioelectronic sinus pain reliever, a device that relieves pain from hay fever.

The non-invasive device targets the most effective areas on the patient’s skin and uses microcurrent waveforms to provide pain relief.

ClearUP’s design allows it to slide across the outside of the nasal passages as it applies low current electrical waveforms to stimulate nerves and relieve pain.

Gramercy’s Nitinol Staple System Cleared by FDA

Gramercy Extremity Orthopedics received FDA clearance for its Nitinol staple system for treating bone-related conditions.

The staple system is cleared to fixate osteotomies and small bone fragments. It’s also cleared for joint fusion surgery.

The device provides an array of sterile symmetric and asymmetric, barbed and smooth nitinol staples that come in various widths and lengths.

IschemaView Gains Expanded Clearance for Neuroimager

The FDA handed medical imaging developer IschemaView expanded clearance for its Rapid neuroimaging platform.

The imaging platform is intended for use in selecting stroke patients that are expected to benefit from endovascular thrombectomy, which treats strokes by pulling blood clots out of arteries.

The company said the Rapid system is the only imaging platform currently approved for selecting stroke patients for blood clot removal.

FDA Clears Immuno Concepts’ Rodent Tissue Slides

The FDA granted 510(k) clearance for Immuno Concepts’ Histofluor rodent liver, kidney and spleen tissue slides.

The rodent tissue slides are available in both mouse and rat substrates, and all components come ready-to-use.

The slides can be used manually or with Immuno Concepts’ Image Navigator device, an automated microscope that can capture multiple images and assemble them into a panoramic view.