Category: Breakthrough

New CMS rule to enable immediate coverage for FDA-designated ‘breakthrough’ devices

Posted on by Nile

Medicare

The agency has finalized a rule that allows it to provide immediate Medicare coverage for FDA-approved products that are deemed “breakthrough devices.” The new coverage process would enable seniors to get access to these devices more quickly, but some provider and payer groups are concerned that this could cause patient harm.

Bone Health’s OsteoBoost Vibration Belt Receives the US FDA’s Breakthrough Device Designation for Osteoporosis

Posted on by Nile
Shots:

  • OsteoBoost receives the US FDA’s BDD to reduce the risk of osteoporosis. It uses vibration technology that delivers mechanical stimulation to the hips & spine at a precise, individually calibrated frequency, encouraging the body to reduce bone resorption & potentially create new bone
  • An initial study showed that just one 30min treatment with OsteoBoost reduced bone loss activity in all participants, showing a decrease of 14%, a reduction on par with bisphosphonate drugs
  • The NIH funded a $2M to study for determining the positive effects of OsteoBoost in a larger study with a broader population. The larger study is currently enrolling patients & is scheduled to be completed in early 2022

Click here ­to­ read full press release/ article | Ref: Bone Health Tech | Image: Linkedin

The post Bone Health’s OsteoBoost Vibration Belt Receives the US FDA’s Breakthrough Device Designation for Osteoporosis first appeared on PharmaShots.

ViiV Healthcare’s Cabotegravir Receives US FDA’s Breakthrough Therapy Designation for HIV Prevention

Posted on by Nile
Shots:

  • This BT designation is based on P-IIb/III HPTN 083 study assessing cabotegravir (q8w) vs. FTC/TDF tablets (qd PO, 200/300 mg) in a study population of 4,566 for HIV prevention. The data were presented at the 23rd International AIDS Conference (AIDS 2020)
  • Results: HPTN 083 study showed that cabotegravir was 66% more effective at preventing HIV compared to daily oral FTC/TDF tablets. The HIV incidence rate is 0.41% in the cabotegravir group and 1.22% in the FTC/TDF group
  • A partner HIV prevention study (HPTN 084) in sub-Saharan African women was stopped earlier this month based upon recommendation of the independent DSMB following the superioriority of cabotegravir to oral FTC/TDF tablets. The company plans to use the data from both the HPTN studies for future regulatory submissions

Click here ­to­ read full press release/ article | Ref: ViiV Healthcare | Image: ViiV Healthcare

The post ViiV Healthcare’s Cabotegravir Receives US FDA’s Breakthrough Therapy Designation for HIV Prevention first appeared on PharmaShots.