Industry news
USC researchers find new blood test to detect early-stage breast cancer
29 September | research
A research team from the University of Southern California (USC) has found that a blood test can detect nano-sized signs of early-stage breast cancer.
Conducted in a small group of patients, the study showed that the liquid biopsy can determine whether a patient has breast cancer in the early stages, as well as the unlikelihood of the disease returning.
The study was conducted in partnership between USC, Epic Sciences, Duke University, Billings Clinic and the USC Norris Comprehensive Cancer Center.
12 September | Deals
DCC HEALTHCARE TO ACQUIRE MEDI-GLOBE TECHNOLOGIES FOR $246.1M
DCC’s healthcare segment has agreed to buy medical devices business Medi-Globe Technologies in a deal valued at nearly $246.1m (€245m) in cash.
The DCC healthcare segment provides products and services to healthcare providers as well as health and beauty brand owners with operations in Ireland, the US, the UK and the DACh region (Germany, Austria and Switzerland).
It operates through two businesses, DCC Vital and DCC Health & Beauty Solutions.
DCC Vital sells and distributes medical products to providers in all sectors of the healthcare market, from hospitals to community and primary care, in Ireland, the UK and DACh regions.
The deal is said to be DCC Healthcare’s largest transaction to date. It also supports a further material expansion of DCC Vital’s presence in the European healthcare market after the purchase of Worner Medical in May 2021.
23 September | Devices
FDA APPROVES DYANSYS’ PRIMARY RELIEF TO TREAT PAIN AFTER CARDIAC SURGERY
DyAnsys has received approval from the US Food and Drug Administration (FDA) for its percutaneous electrical nerve stimulator (PENS) system, Primary Relief, to treat post-cardiac surgery pain.
Primary Relief has been designed for symptomatic relief of pain for up to three days after cardiac surgery using auricular neurostimulation treatment.
Placed in the ear, the wearable, battery-operated PENS device administers periodic low-level electrical pulses to the ear for more than 72 hours.
Through a wire assembly and stimulation needles, the electrical pulses are delivered to the branches of the cranial nerves that are located on the ear.
DyAnsys CEO Srini Nageshwar said: “This ground-breaking device allows for significant pain relief without the use of narcotics.
“By reducing or avoiding the use of opioids after surgery, the risk of addiction is reduced. We look forward to connecting with physicians and patients to make this option available after cardiac surgery among other applications.”
28 September | Devices
NEUROCATCH GAINS HEALTH CANADA APPROVAL FOR IMPROVED PORTABLE BRAIN SCANNER
HealthTech Connex’s subsidiary NeuroCatch has secured a medical device license from Health Canada for the latest version of its NeuroCatch Platform brain function assessment system.
The earlier NeuroCatch generation had already secured approval from the Canadian regulatory authority in 2019 and is presently being used in several clinical studies across North America.
The brain scanner enables quick and objective analysis of cognitive brain function at the point of care and in a matter of minutes.
HealthTech Connex president and chief scientific officer Dr Ryan D’Arcy said: “We’re incredibly proud that Health Canada has quickly provided our latest medical device approval for the next generation of NeuroCatch.
26 September | Deals
NAVERIS RAISES FUNDS TO ADVANCE NAVDX BLOOD TEST COMMERCIALISATION
Life sciences company Naveris has expanded its Series A financing to $33.4m, bringing its total investment to $51m, for advancing the commercialisation of its NavDx blood test.
Led by Gurnet Point Capital, the financing round also included the impact and venture capital arm of the American Cancer Society, as well as BrightEdge and TechU Ventures.
NavDx has been designed to detect cancers that are caused by the human papillomavirus (HPV) in the early stages.
It is claimed to be the first and only clinically validated circulating tumour-tissue-modified HPV (TTMV) DNA blood test.
The blood test uses proprietary technology to quantify fragments of circulating TTMV HPV DNA, which is a unique HPV-driven cancer biomarker shed by cancer cells into the blood.
26 September | Deals
LEUKO RAISES SERIES A FUNDS TO VALIDATE WBC MONITORING SOLUTION
Leuko has raised Series A funding worth $5m for the validation of its non-invasive white blood cell (WBC) monitoring solution, PointCheck, for people with cancer.
HTH VC, Nina Capital, IAG Capital Partners, Good Growth Capital and angel investors all contributed to the funding.
PointCheck is a technology that aids in the monitoring of WBCs in an at-home setting.
To monitor WBC levels without taking a blood sample collection, patients simply place a finger on the PointCheck device for a minute each day.
The device is connected to the internet and sends the collected data to the patient’s care team.
27 September | Devices
PULSE BIOSCIENCES RECEIVES FDA 510(K) APPROVAL FOR CELLFX SYSTEM
Bioelectric medicine company Pulse Biosciences has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its CellFX system.
The clearance enables the indication of the system to be extended to include sebaceous hyperplasia treatment for patients with Fitzpatrick skin types I-III.
The approval was granted based on clinical data from the firm’s investigational device exemption (IDE)-approved trial for sebaceous hyperplasia treatment.
Recently, Pulse Biosciences secured 510(k) approval from the regulatory agency for two more treatment tips with larger spot sizes, specifically the 7.5mm and 10mm tip sizes, to treat larger benign lesions.
The company already offered tip sizes of 1.5mm, 2.5mm and 5.0mm for treatments.
The CellFX system is claimed to be the first commercial product to take advantage of the company’s Nano-Pulse Stimulation (NPS) technology for the treatment of several conditions.
20 January | Covid-19
WALGREENS LAUNCHES INTERACTIVE TOOL TO TRACK COVID-19 VARIANTS
Walgreens has launched a new interactive tracking tool, the Walgreens Covid-19 Index, to advance the rapid detection of Omicron and track variant activity. It says the index can track the spread of the omicron variant within 24 to 48 hours.
The tool uses testing data from Aegis Sciences Corporation and uniquely identifies the spread of current and emerging virus variants in real-time.
The tool offers a snapshot of data for the past seven days based on positive tests analysed at more than 5,000 Walgreens locations across the nation.
According to the data collected and tracked by the tool, more than 95% of all positive cases of Covid-19 nationally are presumed to be the Omicron variant.
In brief
ENZO BIOCHEM INTRODUCES RNA GENE EXPRESSION PLATFORM
Biosciences and diagnostics company Enzo Biochem has launched a new RNA gene expression platform called AMPIVIEW.
Powered by the firm’s LoopRNA in situ hybridisation (ISH) technology, the AMPIVIEW platform features products for human papillomavirus (HPV) detection and analysis.
The new platform will help the company expand its presence in the oncology market as well as open the way for it to move into the spatial biology market.
The AMPIVIEW RNA platform brings together the precision of targeted and sequence-particular probes with the sensitivity of the new LoopRNA ISH technology.
CHECKPOINT SURGICAL INTRODUCES BIPOLAR NERVE STIMULATOR
US-based medical device company Checkpoint Surgical has introduced Checkpoint Gemini, a bipolar nerve stimulator intended to provide precise stimulation.
The single-use, sterile device is designed for providing electrical stimulation of exposed motor nerves or muscle tissue for locating and identifying nerves, as well as testing the nerve and excitability of the muscle.
OLYMPUS INTRODUCES THUNDERBEAT OPEN FINE JAW TYPE X DEVICE
Olympus has introduced the Thunderbeat Open Fine Jaw Type X surgical energy device for open surgery.
The device is a single-use hybrid ultrasonic and bipolar electrosurgical instrument that has been designed for open surgical procedures needing dissection of delicate and fine tissues, such as thyroidectomy or radical neck dissection.
It features a newly developed thermal shield that is designed to support safer procedures.
