It's been a busy September for Ardelyx Inc. so far. Less than two weeks after the Fremont, Calif-based company reported promising pivotal data for tenapanor in chronic kidney disease patients with hyperphosphatemia, the sodium hydrogen exchanger 2 (NHE3) inhibitor won FDA approval for use in irritable bowel syndrome with constipation (IBS-C).

The FDA has granted breakthrough device designation to Sonivie Ltd.'s Therapeutic Intra-Vascular Ultrasound (TIVUS) system for the treatment of pulmonary arterial hypertension (PAH). Early clinical studies suggest that the catheter-based system could stabilize or reduce pressure in the pulmonary vasculature of PAH patients, a population with an average survival rate of five years.

Irvine, Calif.-based Axonics Modulation Technologies Inc., which has developed an implantable rechargeable sacral neuromodulation (r-SNM) device for the treatment of urinary and bowel dysfunction, has won the FDA's nod for its system to help patients with fecal incontinence.

Santa Clara, Calif.-based Shockwave Medical Inc. is working to build its business around the use of intravascular lithotripsy (IVL) in multiple arterial indications. Lithotripsy has been used to destroy kidney stones for decades, but now Shockwave's system is applying that technology to indications including coronary artery disease (CAD), above-the-knee peripheral artery disease (PAD) and below-the-knee PAD that each require a specific catheter.

WASHINGTON – The 2019 annual forum hosted by the Medical Device Innovation Consortium (MDIC) takes place as the National Evaluation System for health Technology (NEST) approaches full operability. Acquiring the data needed to employ NEST as a source of real-world evidence (RWE) is still an issue. Harlan Krumholz, a cardiologist and health care researcher at Yale University and Yale-New Haven Hospital, said that disruption of the business models of the "data oligopolies" is critical for use of RWE for devices in both the pre- and postmarket settings.

The U.S. FDA has granted breakthrough device designation to Laboratory for Advanced Medicine Inc. (LAM) for its liquid biopsy blood test for the detection of liver cancer. The test, which analyzes the DNA methylation pattern of cell-free DNA (cfDNA), is designed to detect the presence of hepatocellular cancer as early as stage 1, with both high specificity and sensitivity.

The FDA's September 2018 draft guidance for considerations of benefit-risk determinations for several device types, including PMAs, said that the agency "intends" to hold an advisory committee hearing if the FDA has any questions about the post-market data generated by the accompanying post-approval study. The final guidance pulls back on that language, but only slightly, stating that the agency "generally expects" to hold an advisory hearing in this circumstance, a difference in language that may or may not translate to a difference in function.

Edwards Lifesciences Corp.'s buy of Cas Medical Systems Inc. (Casmed) this spring appears to have borne fruit. The Irvine, Calif.-based company reported that the U.S. FDA has granted clearance for a smart cable enabling compatibility between the company's Foresight tissue oximetry (brain oxygenation) sensors and the Hemosphere advanced monitoring platform.

A little less than a year after it reported the final close of a series D financing, Miracor Medical SA, of Awans, Belgium, has been granted breakthrough device designation by the U.S. FDA for its Pressure-Controlled Intermittent Coronary Sinus Occlusion (PICSO) Impulse System for the treatment of ST-elevated myocardial infarction (STEMI) patients.