7 medtech stories we missed this week: May 19, 2017

May 19, 2017 By Danielle Kirsh Leave a Comment

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From FDA clearances to touting study data, here are 7 medtech stories we missed this week but thought were still worth mentioning.

1. XpandOrtho wins FDA 510(k) clearance

XpandOrtho announced in a May 17 press release that it has received FDA 510(k) clearance for its electronic soft tissue balancing instrument for total knee replacement surgery. The sterile-packaged wireless disposable device uses miniature sensors and actuators to balance knee joints during full-range motions. Using constant pressure bellows systems, the device communicates with a display for multiaxial balance and selection of thickness and tibial component.

2. Visionsense goes after Novadaq patent

Visionsense has filed an IPR with the USPTO for its Novadaq Technologies’ U.S. patent, according to a May 16 press release. The patent is for a method for using fluorescence angiography to assess patency of vessel grafts. It is the only patent that Novadaq lists on its website as being associated with the SPY Elite system.

3. FDA clears Body Vision Medical’s LungVision navigation system

Body Vision Medical announced in a May 15 press release that it received FDA clearance to market its LungVision imaging system that enables accurate, real-time navigation and lesion localization during bronchoscopy procedures. LungVision has gone through clinical trials in the U.S., where it has been shown to be a sophisticated augmented reality approach for physicians to visualize, plan and track endobronchial tools and radiolucent lesions in real-time. The system also uses intraoperative fluoroscopy and pre-operative high-resolution imaging.

4. Rivanna Medical touts Accuro spinal navigation data

Rivanna Medical is touting data from its Accuro automatic spinal navigation system trial, according to a May 15 press release. The Accuro navigation system enhances the accuracy of epidural and spinal anesthesia placement for residents-in-training and patients with atypical spinal anatomy. The randomized trial was conducted at the University of Virginia and compared anesthesiology residents’ success placing spinal anesthesia in C-section patients using Accuro with traditional methods. The trial showed that residents who had prior spinal anesthesia experience had improved first-attempt needle placement using Accuro. First-attempt needle placement improved more than 100% in patients with a high body mass index. The second clinical trial, held at Stanford University, showed that Accuro identified appropriate spinal interspace for needle insertion in 94% of patients and was 87% successful in first-attempt epidural administration. The third trial, at Rutgers University, showed that Accuro successfully identified bony landmarks and the optimal spinal interspaces for anesthesia delivery.

5. Exactech gets 510(k) clearance for computer-aided shoulder arthroplasty technology

Exactech announced in a May 15 press release that it has received FDA 510(k) clearance to market its ExactechGPS Shoulder Application. Exactech combines preoperative planning with computer-assisted surgery for greater intraoperative visibility in both standard and challenging shoulder arthroplasty. It is designed to be a preoperative planning tool to help surgeons understand patient anatomy before surgery. It allows for visibility into the glenoid vault in real-time and allows physicians to have consistent and accurate glenoid placement.

6. NxThera touts 2-year Rezum prostate treatment

NxThera announced the 2-year outcome data for its Rezum System clinical trial to treat lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia, according to a May 15 press release. The study showed that there was significant LUTS relief that stayed durable 2 years after treatment. 197 patients were enrolled in the study. The data showed durable symptom reduction and preserved sexual function in patients who were treated with Rezum.

7. Lombard launches Altura registry study

Lombard Medical announced in a May 15 press release that it has enrolled and treated the first patient in its global registry to evaluate Altura Endograft System. The study is being conducted on 1,000 patients in clinical use conditions. Altura Endograft System study is designed to study the impact on the treatment of abdominal aortic aneurysms using a D-stent EVAR design.

Here’s what we missed last week.

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Integer adds IPG manufacturing and testing tech to Mexico plant
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FDA issues draft guidance on multi-use arthroscopy tubing sets
The FDA has issued draft guidance on arthroscopy pump tubing sets intended for multiple-patient use. Clinicians often use a single source of irrigation fluid for multiple patients without replacing the source of irrigation fluid or replacing/reprocessing the irrigation tubing system between patients. These devices are designed to deliver irrigation to the surgical site, these devices… […]
How LED light can break down ingestible medical devices
Researchers at the Massachusetts Institute of Technology have developed an approach to break down ingestible medical devices in the gastrointestinal tract. Medical devices can be inserted in the gastrointestinal tract to treat, diagnose or monitor a number of GI disorders. However, the devices have to removed through endoscopic surgery once completed. The MIT researchers developed… […]
New 510(k) boosts iRhythm, Verily efforts for AFib screening
The latest 510(k) clearance for the Verily Study Watch will further the efforts of the Google sister company and iRhythm Technologies (NSDQ:IRTC) to improve atrial fibrillation treatment. Verily — a life science company under Alphabet (NSDQ:GOOGL) — recently received an FDA 510(k) clearance to include an irregular pulse monitor in its Study Watch wearable. “We’ve worked carefully to meet the FDA’s stringent… […]
Argon Medical debuts IVC filter retrieval kits
Argon Medical Devices (Frisco, Texas) said this week that it has launched single-loop and triple-loop retrieval kits for percutaneous removal of inferior vena cava (IVC) filters that are no longer medically required. The kits are indicated for use via a jugular approach and offer the following features: A coil-reinforced outer sheath with the strength needed… […]
NANS 2020: Neuromodulation news you need to know
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Injection Molding Principles
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GW Plastics expands Vermont manufacturing and tech center
GW Plastics announced that it has completed a $10 million expansion of its Royalton, Vt., manufacturing and technology center. The company said it has added a 30,000 ft2 to the building to accommodate the growth of its thermoplastic injection molding and medical device contract assembly business. The expansion includes a new 13,000 ft2, Class 8… […]
Certain GE Healthcare patient-monitoring devices vulnerable to cyberattack
The federal government and GE Healthcare (NYSE:GE) announced today that the certain of the company’s patient monitoring devices are vulnerable to cyberattack. If attacked, some versions of the Carescape and ApexPro telemetry servers, the Carescape Central Station version 1 and Central Information Center systems could stop monitoring patients, silence alarms or produce unnecessary alarms during… […]
Cardinal Health recalls 9 million surgical gowns, sends hospitals scrambling
Cardinal Health (NYSE:CAH) announced that it is voluntarily recalling 9.1 million surgical gowns produced by an unnamed contract manufacturer after discovering quality issues with the product. The Dublin, Ohio-based company said that some gowns were produced in unapproved locations that did not maintain proper environmental conditions as required by law. Some of the gowns were also… […]