FDA clears Insightec Exablate Prostate device

Insightec announced today that it received FDA 510(k) clearance for its Exablate Prostate system for treating prostate tissue.

Haifa, Israel-based Insightec designed its Exablate Prostate system to use high-intensity focused ultrasound to ablate targeted tissue in the prostate. The procedure is performed under magnetic resonance imaging (MRI) guidance for high-resolution visualization of the patient’s anatomy for precise targeting and real-time temperature monitoring.

According to a news release, the treatment does not require incisions and is performed in a single session, allowing patients to quickly return to normal activity with minimal complications.

Clinical trial results demonstrated that the Exablate Prostate system resulted in minimal damage to adjacent structures with low rates of impact on potency and continence, Insightec said.

“Insightec remains focused on achieving strategic milestones and expanding into indications beyon…

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MedTech 100 roundup: Industry roars back

In the blink of an eye, the medtech industry exited its spring slump and neared its all-time best performance levels.

MassDevice‘s MedTech 100 Index offered signs of a rebound last week and has built on that momentum, registering a final tally of 109.39 points on April 9. That represents a 2.9% increase from the 106.26-point mark set a week prior (April 2).

The industry’s rebound has been impressive, given that just over one month prior, the index had dropped to 102.16 points (March 8), having just set its all-time best of 110.96 on Feb. 15. Medtech companies had no seen that degree of a fall since October 2020.

Improvements highlight the secure position the industry has nestled into a year on from the height of the COVID-19 pandemic’s impact on medtech, as the industry has produced an 18.5% rise from the pre-pandemic high of 92.32 (set on Feb. 19, 2020), plus a 76.1% increase from the mid-pandemic low of 62.13 (March 23, 2020).

The overall …

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Insightec raises $136M for incisionless surgery tech

Insightec raised more than $136 million in a recent funding round, according to a Form D that the incisionless surgery tech company filed today with the SEC.

The Tirat Carmel, Israel–based company — which has technology that uses MR-guided focused ultrasound to perform surgeries — had sought a total of $150 million in the money-raise. The company said 16 investors participated in the offering.

The Form D filing comes only months after Royal Philips (NYSE:PHG) announced a collaboration with Insightec to expand access to MR-guided focused ultrasound. Amsterdam-based Philips plans to develop compatibility between its advanced MR system and Insightec’s Exablate Neuro platform to expand access to MR-guided focused ultrasound for incision-less neurosurgery in treating essential tremor and other neurological disorders.

Koch Disruptive Technologies has been among the leading investors in Insightec.


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Insightec wins Medicare coverage for incisionless neurosurgery platform

Insightec announced today that it has secured complete Medicare coverage across the U.S. for its MR-guided focused ultrasound treatment of medication-refractory essential tremor.

The coverage comes roughly four years since the Tirat Carmel, Israel–based company won FDA approval for the technology.

Insightec officials said compelling clinical evidence and support from physicians, specialty societies and patients enabled the company to achieve coverage in the final two Medicare jurisdictions. The company has worked closely with the seven Local Medicare Administrative Contractors over the past 18 months.

“Complete Medicare coverage is a significant milestone for Insightec and brings the incisionless treatment option to millions of people,” Dr. Maurice R. Ferré, Insightec’s CEO, said in a news release. “This is the critical next step in our mission to make focused ultrasound a standard of care to improve the lives of people living wit…

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