From Guardant suing Foundation Medicine to Interson receiving 510(k) clearance for ultrasound probes, here are medtech stories we missed this week but thought were still worth mentioning.
1. Guardant levels false advertising suit against Foundation Medicine
Guardant Health announced in a June 22 press release that it has filed a lawsuit against Foundation Medicine for false advertising and unfair competition. Guardant Health is claiming that Foundation Medicine’s advertising causes harm to Guardant Health and its patients because it misleads oncologists about the sensitivity and accuracy of the Guardant 360 assay and Foundation Medicine’s own assay. The complaint also says that Foundation Medicine promotes its assay as being “best in class” with “unparalleled” sensitivity, even though multiple research proves otherwise. Guardant Health is asking the court to stop Foundation Medicine from making false and misleading claims about its assays and the Guardant360 and wants Foundation Medicine to retract, remove and correct false and misleading advertising claims.
2. FDA clears Meditech Spine’s Talos Lumbar device
Meditech’s Talos Lumbar (HA) Peek IBF spinal surgery device has received FDA 510(k) clearance to be marketed, according to a June 19 press release. The device is an intervertebral body device that is designed to be used in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. The Talos Lumbar Peek IBF device is also designed to be used with autograft and/or allograft that is made of cancellous and/or corticocancellous bone graft.
3. Neurotech company Rythm launches sleep-enhancing device
Neurotechnology startup company Rhythm announced in a June 15 press release that it has officially launched its Dreem sleep solution that monitors, analyzes and acts on your brain to enhance sleep. The device consists of a headband that monitors brain activity and uses auditory stimulation to assist in falling asleep faster and getting a deeper sleep. It also helps users wake up refreshed. The headband consists of dry polymer EEG electrodes while the headband independently analyzes brain activity with an internal CPU. The front of the device has a bone-conduction technology that emits sound directly to the inner ear.