Industry news
HEARTLAND HEALTH LAUNCHES NEW SURGICAL FACE MASKS
05 January | Device development
Healthcare products manufacturer Heartland Health has announced a new style of surgical face masks as Covid-19 cases in the US are rising.
The latest face masks have gaiter style design and are worn around the neck. Compared to the ones worn over the ears, they have various benefits.
The masks are designed to provide a comfortable and closer fit to the face and are adaptive to facial curves.
Furthermore, they can be fixed to the nose using an embedded nose wire and an elastic band that can aid in maintaining breathability while lowering the chances of disease transmission.
Heartland Health’s face masks have an internal filter that surpasses the surgical and N95 mask filtration standards, eradicating harmful airborne pathogens before they are inhaled to stop disease spread.
Furthermore, the face masks do not get in the way with glasses, hearing aids, or any facial accessories, increasing accessibility.
Authorised by US Food and Drug Administration (FDA) under a EUA, the product can be used by healthcare personnel (HCP) in healthcare settings as personal protective equipment (PPE) to offer a fluid and particulate material physical barrier to prevent HCPs being exposed to respiratory droplets and large particles.
Through the USA Promise Program, Heartland Health will put a percentage of sales into use to produce masks to be donated to organisations in the country.
The company is setting up a new, domestic PPE supply chain. In addition, it is creating jobs and requires less dependence on foreign nations while sourcing raw materials locally.
05 January | Approvals
CYTOSORB RECEIVES HEALTH CANADA AUTHORISATION TO TREAT COVID-19
Health Canada has granted Medical Device Authorisation for the importation, sale, and emergency use of critical care immunotherapy company CytoSorbents’ blood purification technology to treat hospitalised Covid-19 patients under Interim Order (IO) ID# 316575.
CytoSorb is used to treat fatal inflammation in critically ill and cardiac surgery patients worldwide.
It will be commercially available in North America and 67 other countries across the world for use in Covid-19 patients.
The company will partner with speciality medical products distributor in Canada, ebbtides medical, to make the treatment available rapidly and extensively.
The IO of the Canadian Government helps to make health products available to fight public health emergencies such as the Covid-19 pandemic.
CytoSorbents president and chief operating officer Vincent Capponi said: “Cases of Covid-19 have been steadily rising in Canada with approximately 600,000 confirmed cases already."
04 january | approvals
TURN THERAPEUTICS TO SEEK FDA APPROVAL FOR FLEX ANTIMICROBIAL
Advanced wound care innovator Turn Therapeutics has received positive data for its absorbent, antimicrobial regenerative wound matrix, Flex Antimicrobial.
The company is all set to seek 510k clearance from the US FDA.
Flex blends Turn’s FDA-cleared Hexagen antimicrobial formula with an FDA-cleared regenerative collagen powder through a cold mixing process in a ratio of 20%:80%
The combination results in a first-of-its-kind, malleable product that can potentially stimulate healing while absorbing drainage and lowering bioburden.
Turn Therapeutics CEO and founder Bradley Burnam said: “Combining regenerative properties with antimicrobial and absorbent capabilities is a first in the advanced wound care space.
“There are currently very limited options for reducing bioburden while stimulating healing through regenerative ingredients and none that combine all the attributes Flex appears to offer. We expect to file for 510k clearance in the coming weeks and look forward to working with the FDA to bring this product to clinicians.”
30 december | covid-19
APPLIED DNA-CLEARED4 COLLABORATION FOR POOLED COVID-19 SURVEILLANCE TESTING PROGRAMME
Applied DNA Clinical Laboratories (ADCL), a wholly-owned subsidiary of Applied DNA Sciences, has entered into a reseller and sales referral partnership with US-based health safety solutions provider CLEARED4.
According to the terms of the deal, ADCL can resell subscriptions to CLEARED4’s platform as part of the former’s safeCircle pooled Covid-19 surveillance testing programme.
In addition, CLEARED4 can refer its customers seeking pooled Covid-19 surveillance testing to ADCL.
ADCL’s safeCircle laboratory testing operations have been integrated with CLEARED4’s return-to-work health safety platform for ADCL customers as a value-added option.
safeCircle puts into use frequent, high-sensitivity pooled testing in a bid to prevent the Covid-19 spread by rapidly detecting infections within a community, workplace or school.
It can deliver results with the help of real-time PCR testing in 24 hours.
28 december | regulation
INTERSCOPE’S ENDOROTOR SYSTEM GRANTED FDA DE NOVO CLEARANCE FOR NECROSECTOMY
Interscope has received US FDA de novo clearance to market its EndoRotor System in the country for direct endoscopic necrosectomy (DEN). The DEN procedure is a minimally invasive treatment for walled-off pancreatic necrosis.
Acute pancreatitis progresses to walled-off necrosis (solid diseased tissue), which is managed using endoscopic ultrasound-guided drainage procedures.
The EndoRotor System aids the physician in simultaneous resection and aspiration of necrotic material from a walled-off pancreatic collection under direct endoscopic visualisation through a lumen apposing metal stent or cystogastrostomy.
24 December | approvals
FDA GRANTS EUA TO QUIDEL’S COVID-19 MOLECULAR TEST
The US FDA has granted emergency use authorisation (EUA) to Quidel for marketing its Solana SARS-CoV-2 Assay for the qualitative detection of nucleic acid from SARS-CoV-2.
The isothermal Reverse Transcriptase – Helicase-Dependent Amplification (RT-HDA) assay detects nucleic acid from the virus in nasopharyngeal and nasal swab specimens in viral transport media from patients suspected of Covid-19 by their healthcare provider.
It offers a simple workflow with no sample extraction, a medium volume throughput design ideal for batch testing and enhanced lab efficiency, as well as fast, 25-minute run time for up to 11 samples.
In brief
AFRICA UNION COMMISSION RELEASES GUIDANCE ON COVID-19 ANTIGEN TESTING
The Africa Union Commission has released a new ‘Guidance on the Use of Rapid Antigen Tests for Covid-19 Response’ to rapidly increase antigen testing in the continent. The guidance was released through the Africa Centres for Disease Control and Prevention and partners.
NOWDIAGNOSTICS COVID-19 ANTIBODY FINGERSTICK TEST OBTAINS CE MARK
NOWDiagnostics has received Conformité Européene (CE) Mark approval for its ADEXUSDx Covid-19 ‘antibody fingerstick’ Test, a rapid serology, self-contained assay. The test can now be used in 28 countries in the EU. NOWDiagnostics subsidiary, C19 Development, will start offering the test for fingerstick use in various healthcare settings in the EU and commence its clinical trials for use over the counter.
SPOTSEE INTRODUCES TEMPERATURE THRESHOLDS TO WARMMARK INDICATORS
US-based SpotSee has introduced new temperature thresholds for its WarmMark indicators in a bid to address temperature needs associated with vaccines for Covid-19. The indicators will be used to check whether temperature and time tolerances are maintained while transporting and before administration of Covid-19 vaccines.
SIGNIFICANT DISPARITIES FOUND IN SYMPTOM ASSESSMENT APPS
Digital health researchers have found significant variance in coverage, accuracy and safety among the eight most popular online symptom assessment apps, raising questions about how ready some of these technologies are for use in clinical settings.
EFEMORAL MEDICAL INITIATES STUDY OF VASCULAR SCAFFOLD SYSTEM IN HUMANS
Interventional bioresorbable therapy developer Efemoral Medical has announced the EFEMORAL I FIH clinical study, involving first-in-human use of its Efemoral Vascular Scaffold System with FlexStep Technology.
24 december | approvals
UK AUTHORISES 30 MINUTE SELF-TEST KIT TO DETECT ASYMPTOMATIC COVID-19 CASES
The UK Medicines and Healthcare products Regulatory Agency has issued exceptional use authorisation for an NHS Test and Trace Covid-19 Self-Test device.
The Department of Health and Social Care was granted authorisation to use the rapid test kit for detecting infection in asymptomatic people.
This is an antigen lateral flow test, which is capable of delivering results in 30 minutes.
The device can be used to detect new Covid-19 cases in those individuals who do not have symptoms.
Individuals with no prior knowledge of testing can use a self-test device in their own home or another community setting.
22 December | regulation
FDA GRANTS EUA TO SCONE MEDICAL SOLUTIONS’ DEVICE
The US FDA has granted EUA to SCONE Medical Solutions’ Self-Contained Negative Pressure Environment (SCONE).
Using negative pressure technology, the SCONE device provides ‘active’ barrier protection and helps hospitals to lower the risk of infectious aerosol exposure to healthcare workers.
Apart from reducing the spread of transmissible diseases, the disposable, low cost and easy to use device can boost hospital throughput and enhance the quality of patient care.
SCONE Medical Solutions designed and developed the device in partnership with medical device developer Gilero and clinical support from Mayo Clinic.
SCONE Medical Solutions CEO Mike Adams said: “Our choice to partner with Gilero for the design and development of the SCONE device has given us a clear advantage in our speed to market."
In brief
Chumakov Center initiates Covid-19 vaccine candidate trials
Russia’s Chumakov Center has started clinical trials of its potential Covid-19 vaccine in St Petersburg. The 30 participants are healthy volunteers aged 18-45 years who tested negative for Covid-19 and with the absence of antibodies to the virus.
Edesa Biotech gets FDA approval to trial EB05 for Covid-19 treatment
Edesa Biotech has received FDA approval to initiate Phase II clinical trial of its investigational drug EB05 to treat hospitalised patients with Covid-19. EB05 treatment aims to suppress fluid accumulation, lung injury and inflammation.
Dr Reddy’s and RDIF receive DCGI approval for Sputnik V human trial
Dr Reddy’s Laboratories and Russian Direct Investment Fund (RDIF) have received approval from the Drug Control General of India (DCGI) to conduct a Phase II/III human trial of Sputnik V Covid-19 vaccine in India.
Russia grants approval to second vaccine for Covid-19
Russian health authorities have approved the Covid-19 vaccine EpiVacCorona, developed by the Vector State Virology and Biotechnology Center in Siberia. Researchers tested the vaccine in Phase I and II trials prior to receiving provisional registration.
FDA approves ImmunityBio Phase I Covid-19 vaccine trial
ImmunityBio has received FDA clearance to initiate a Phase I trial of its novel Covid-19 vaccine candidate, hAd5-COVID-19, which is engineered to activate T-cells and antibodies against SARS-CoV-2.
